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Decision 09HDC01870
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Names have been removed (except Professor Stubbs and the
experts who advised on this case) to protect privacy. Identifying
letters are assigned in alphabetical order and bear no relationship
to the person's actual name.
Gastrointestinal and Hepatobiliary Surgeon,
Professor Richard Stubbs
A Report by the Health and Disability Commissioner
Overview
This complaint relates to the adequacy of the information
provided by Professor Richard Stubbs to Mr A prior to surgery at a
private hospital on 4 December 2007, and the quality of the care
provided following the surgery. Mr A (aged 64) had colorectal
cancer with liver metastases,[1] and
chemotherapy was no longer effective. He was referred to Professor
Stubbs for consideration of Selective Internal Radiation Therapy
(SIRT) and Hepatic Artery Chemotherapy. On 4 December 2007 he
underwent an anterior resection of the rectum, a cholecystectomy,
and an insertion of a hepatic artery port-a-cath for SIRT. He made
a slow recovery and, on 17 December 2007, a chest X-ray and CT scan
indicated the development of an anastomotic leak or other viscus
perforation within the abdomen. He was transferred to the public
hospital for surgery and discharged home on 18 January 2008. Mr A
did not undergo the SIRT and died two months later.
Complaint and investigation
On 24 July 2008 the Health and Disability Commissioner (HDC)
received a complaint from Mrs A about the services provided by
Professor Richard Stubbs to her husband, Mr A. An investigation was
commenced on 2 September 2008 into the appropriateness of the care
provided by the private hospital, Professor Richard Stubbs and a
district health board (Hospital 2).
On 18 February 2009, HDC decided that DHB representatives should
meet with Mrs A. No further action was proposed in relation to the
private hospital.
On the basis of expert advice obtained from Professor Bryan
Parry, HDC referred Professor Stubbs to the Medical Council of New
Zealand with a recommendation that a competence review be
performed. The Medical Council decided not to carry out a review,
but asked Professor Stubbs to report back to them in six months'
time.
On 18 March 2009, Professor Stubbs requested that HDC re-open
the file to give him an opportunity to comment on Professor Parry's
advice, with which he disagreed. He stated that he had expert
advice supporting his view available from three colorectal
surgeons.[2]
HDC obtained further information from Mrs A and Mr B, Mr A's
son-in-law.
After a review, HDC concluded that, as new information had
become available, the overall justice of the situation required
that the matter be reconsidered.
The investigation was re-opened on 1 September 2009.
The following issue was identified for investigation:
- The appropriateness of care provided by Professor Richard
Stubbs to Mr A, including the adequacy of the information
provided.
The parties directly involved in the investigation were:
Mrs A Consumer's wife
Mr B
Consumer's son-in-law
Professor Richard Stubbs
Surgeon/Provider
The private
hospital
A private hospital
Hospital
2
A public hospital/DHB
Information was reviewed from Mrs A, Mr B, Professor Stubbs, the
private hospital and Hospital 2.
Independent expert advice was obtained from general and
hepatobiliary surgeon Dr Peter Johnston (attached as
Appendix A) and colorectal surgeon Professor Bryan
Parry (attached as Appendix B). Professor Stubbs
obtained expert advice from colorectal surgeon Dr Richard Perry
(attached as Appendix C). Professor Parry was
asked to comment on Professor Stubbs' response to my provisional
opinion and Dr Perry's advice. Professor Parry's further expert
advice is attached as Appendix D.
Key events
Treatment at Hospital 1
In June 2006 Mr A was diagnosed as having a colorectal cancer
with liver metastases and the primary recto-sigmoid tumour in situ.
He was treated at the nearest public hospital (Hospital 1) with
first line chemotherapy[3] using a Folfex
regimen, which had good initial effects for some months. However,
his disease began to progress and he was commenced on second line
chemotherapy with Folfiri, to which he had a poor response.
Around August or September 2007 he developed symptoms of
subacute bowel obstruction related to his primary bowel tumour,
which was managed non-operatively with high dose steroids. He took
dexamethazone[4] for relief of his obstructive
symptoms. Mr A was advised that there was no further systemic
chemotherapy available to him.
A medical oncologist at the hospital referred Mr A to Professor
Stubbs for consideration of Selective Internal Radiation Therapy
(SIRT) and Hepatic Artery Chemotherapy (HAC) to treat his extensive
liver metastases originating from a primary tumour at or close to
the recto-sigmoid junction of the bowel.
Consultation at the private hospital
On 18 November 2007, Mr A attended his first appointment with
Professor Stubbs, accompanied by his son-in-law, Mr B. Professor
Stubbs advised that clinical examination of Mr A revealed a grossly
enlarged liver from metastatic disease, which was shown by the CT
scan performed at Hospital 1. Rectal examination and
sigmoidoscopy[5] confirmed the presence of a
tumour 12cm from the anal margin.[6] Mr A
indicated that he was keen to pursue any option that might extend
his life. Professor Stubbs told him that SIRT followed by HAC was a
possibility that had a good prospect of controlling his liver
disease, at least for a period of time.
Professor Stubbs explained to Mr A that it would be necessary to
remove his bowel tumour because he already showed symptoms
suggestive of incipient bowel obstruction, although the symptoms
had been largely controlled by the use of high dose steroids.
Professor Stubbs proposed an operation in which an anterior
resection of rectum would be performed to remove the primary
tumour, with probable primary anastomosis plus cholecystectomy,[7] and insertion of a hepatic artery
port-a-cath[8] for the purposes of SIRT
delivery of yttrium microspheres[9] via the
hepatic artery[10] and subsequent HAC.
Information provided to Mr A
Professor Stubbs says that he discussed the SIRT option in some
detail, and the risks of the procedure were thoroughly outlined to
Mr A. Prior to seeing Professor Stubbs, Mr A had read his patient
information booklet on the subject of liver cancer, which explained
the SIRT treatment. Professor Stubbs apparently indicated to Mr A
that the benefits of this approach would only be gained if there
were no major complications from his bowel surgery and he obtained
a good response from the SIRT. In relation to the risks of the
operation itself, Professor Stubbs says that he explained the
difficulties resulting from the position of the bowel tumour at
about 12cm from the rectum, which made the procedure more difficult
than a tumour higher in the bowel:
"I also explained that there were significant risks attached to
anterior resection of rectum, including the possibility of a leak
leading to peritonitis and the need for further surgery. I judged
this risk to be around five percent or greater particularly because
of his high dose steroid therapy and his relatively advanced state
of metastatic disease. Both of these circumstances are known to be
associated with a high rate of failure of healing at the
anastomosis."
He told Mr A that his chance of dying from the surgery was
1%.
Mr A's son-in-law, Mr B, who was present at the consultation,
recalls the information disclosed about the risks and likely
success of the SIRT treatment as follows:
"Professor Stubbs advised the SIRT treatment would offer [Mr A]
an extension to his life of up to one year of comfortable and
symptom free living. He outlined that with the cancer being
advanced and the fact that [Mr A] had already had two courses of
chemotherapy, the likelihood of success for the SIRT was reduced
from around 90% success to around 2/3rds (66%) success. He also
warned [Mr A] that if the SIRT was not successful then his life
would be shortened and he would suffer a painful last few months.
That was made clear."
…
"… [T]here was then some discussion about the need for a
bag. Professor Stubbs advised that he would take the option of not
using a bag for [Mr A's] procedure (I can't quite recall the
reasons why he decided that). The second part of the conversation
was around the risks of the operation to remove the tumour, remove
the gall bladder and insert the catheter into the liver for the
SIRT treatment. This was a conversation along the lines of any
conversation a doctor would give to a patient before a major
operation. The risks here appeared to [Mr A] and me to be no
greater than usual. We discussed this after the consultation."
Mr B stated that Professor Stubbs mentioned a risk of a major
complication of around 1%, which he thought sounded like the normal
thing said by a surgeon to a patient when discussing risks.
Professor Stubbs then went on to talk about the cost of the
operation, $40,000-50,000, which Mr A said he was willing to pay.
They then discussed proposed dates for the surgery.
Clinical notes
Professor Stubbs recorded the following in the clinical
notes:
"Keen to do what he can.
- rationale of SIRT / HAC explained
- rationale of resection of 1° explained
Risks of anterior resection
- leakage 5% / peritonitis
- Port placement
) 1% mortality
- SIRT
) risks /
uncertainties / results
Not curative -
- relies on good recovery - 65%
- relies on no complications from bowel surgery."
Surgery at the private hospital
Mr A was admitted to the private hospital on 3 December 2007. He
consented to an anterior resection of the rectum, a
cholecystectomy, and an insertion of a hepatic artery port-a-cath
for SIRT. The operation was performed on 4 December. The plan was
to deliver the SIRT on 14 December, which allowed a 10-day interval
between the surgery and the SIRT. Professor Stubbs allowed a longer
time than the usual three to seven days because of his concern
about Mr A's recovery from bowel surgery, and because he did not
want to deliver high dosage radiation into Mr A's liver until he
was happy that the bowel anastomosis had healed. During the
intervening period it was planned to reduce Mr A's dose of
steroids.
The operation proceeded satisfactorily and was completed in
three hours 14 minutes. Five units of blood in total were given
during and after the operation to correct Mr A's pre-existing
anaemia and replace an estimated blood loss of 700-800 mls.
Postoperative progress
Mr A showed reasonable clinical progress over the first few days
after surgery. His clinical records show a relatively normal pulse,
temperature, satisfactory blood pressure, normal respiratory rate
and normal urine output. However, he became oedematous[11] and his abdomen became distended.
Mrs A, who was present with her husband during his
hospitalisation, recalls that the doctors discussed with Mr A the
need for him to pass flatus,[12] as this was
an indicator of successful surgery. Because it was emphasised as
being important, the family asked Mr A about this issue every day.
They believe he did not pass flatus. Mrs A stated, "My recall of
this is very clear because it was so acutely important that it
became almost a joke that we all asked him constantly if he had
passed flatus and laughed about it." Professor Stubbs states that
bowel sounds commenced at an early stage and Mr A passed flatus by
day three postoperatively. The clinical record for 6 December 2007
has a notation made by Professor Stubbs' registrar, "passed
flatus", and this is supported by the nursing record.
A chest X-ray was taken on 7 December and a further chest X-ray
with erect and supine abdominal films on 10 December, because of
continuing abdominal distension. Neither of the X-rays showed signs
of free gas to suggest an anastomotic leak. The abdominal X-rays
taken on 10 December showed slightly prominent loops of large
bowel, but no convincing evidence of obstruction. Professor Stubbs
advised that these were not unexpected at this stage. Until 17
December he was reassured that there was no major problem requiring
further surgery, as there was no tachycardia, elevated temperature
or elevated blood count to suggest developing infection. He stated,
"We anticipated gradual improvement in his condition with the
passage of time." Professor Stubbs reassured Mr and Mrs A that his
slow progress was not unexpected in view of his large burden of
metastatic disease.
Mrs A, who is a registered nurse, recalls that her husband was
deteriorating daily, although the hospital staff assured her that
he was progressing. She saw no signs of progress from the third day
after surgery, and she was concerned about his levels of pain.
SIRT delayed
The original plan was that Mr A would undergo SIRT on 14
December 2007 but it was delayed for one week until 21 December.
Professor Stubbs said that the need to delay the SIRT in light of
his slow recovery coincided with a production problem of the
yttrium microspheres in Sydney, which mandated a delay of one week.
Mrs A is very clear that the nursing staff were embarrassed and
distressed that the treatment was delayed solely because of a
faulty batch of yttrium microspheres, rather than Mr A's
condition.
16 December 2007
On Sunday 16 December Mrs A became distressed about Mr A's
condition and believed he was dying. She requested that
arrangements be made for him to be flown home. The private hospital
nurses telephoned Professor Stubbs and he came in. The hospital
notes refer to low oxygen saturations. Mrs A recalls Mr A's extreme
pain, grey colour and that he was cold and clammy. Mrs A said that
Professor Stubbs "told me that he was at home and that family time
was important to him".
Mrs A recalls:
"[R]ather than assess [Mr A's] condition Professor Stubbs
maintained he just needed to eat more and exercise which was
obviously well beyond his means. [Mr A ] did say to me on one
occasion, 'get me up for this bloody walk then, fat lot of use it
will do', and he could barely get the words out; we got as far as
the door to his room and we had to give up as it was so clearly
impossible for him to do … this was a man so close to dying that
the request to eat and exercise were totally unrealistic and
Professor Stubbs should have absolutely known this from
professional experience."
Professor Stubbs noted in the medical record, "Slow progress but
no obvious complication from bowel surgery. Oedema
limb/trunk/genitals an issue - complicated by surgery, metastatic
load, low protein, steroids." He recorded, "May or may not tolerate
SIRT - delay of a week is a shame, but not available."
Professor Stubbs recorded that he had a "full frank discussion
with [Mr A], his wife and daughter. He is very keen to receive SIRT
otherwise would die in next three to four weeks. May do so anyway."
Professor Stubbs ordered albumin infusions and frusemide in an
effort to improve Mr A's serum albumin and reduce his oedema. He
encouraged fluids and food intake and commenced Mr A on oral
morphine for his pain.
17 December 2007
On the morning of 17 December Mr A developed nausea and vomiting
and had an elevation of his pulse rate to 110. He was seen by
another doctor as Professor Stubbs was in another city that day. A
chest X-ray revealed a large pneumoperitoneum,[13] which indicated the development of an
anastomotic leak or other viscus perforation within the abdomen.
The doctor arranged for a CT scan, which showed extensive
intra-peritoneal free gas and fluid. This suggested a viscus
perforation. The doctor discussed the options for treatment with Mr
and Mrs A. The options were either to do nothing other than provide
support and palliative care, or to reoperate to treat the
peritonitis and presumed anastomotic leak.
The decision was made to move Mr A to the nearest public
hospital (Hospital 2) for surgery. Professor Stubbs stated that the
decision to proceed to surgery was "largely on the basis of Mr A's
determination to get through to have the SIRT and HAC which he had
originally sought". Mrs A stated that "the reason we made the
decision to move him was not about wanting the SIRT treatment to
extend his life, but rather about ensuring he didn't have a painful
death, as explained by [the doctor] to [my daughter]. So again, we
were really realistic about what was happening to [Mr A]."
In his response to the complaint, Professor Stubbs said that the
perceived advantages of a transfer to the public hospital were that
Mr A would need a level of intensive care over and above that
provided at the private hospital, given his poor general status. Mr
A was uninsured, and the cost of further surgery and intensive care
may have been prohibitive. In addition, it was expected that the
private hospital would be winding down for Christmas and closing
for a period after Christmas.
On 17 December Mr A underwent a laparotomy, washout, division of
colorectal anastomosis and end colostomy. The operation note
records: "Large (1cm) defect posterior part of staple line at
colorectal anastomosis." He was grossly oedematous from his waist
to his feet, with pitting.
On 21 December, Professor Stubbs reported to Hospital 1's
medical oncologist and suggested that if Mr A was well enough he
could receive yttrium in January. However, he thought Mr A's
condition would continue to deteriorate and he would require only
palliative care. He stated, "It is always difficult and potentially
problematic when patients come with such advanced disease when they
still face significant surgery such as anterior resection of the
rectum."
Professor Stubbs' involvement with Mr A ended at the point of
his transfer to Hospital 2, although he did visit him there on at
least one occasion following his surgery.
Discharge home
After a slow recovery from the surgery, Mr A was discharged home
on 18 January 2008. Professor Stubbs spoke to Mrs A on the
telephone on 5 February and again on 11 February. Professor Stubbs
stated:
"We agreed that his general condition was not sufficiently good
for him to be considered for SIRT. It seems [Mr A] himself had by
this time become resigned to not ever receiving the SIRT he
originally sought. I left it with his wife that they were free to
contact me if his condition rallied sufficiently that they wished
that decision to be reconsidered. At that stage I refunded to him
the $15,000 that he had advanced for SIRT therapy prior to his
admission to [the private hospital]."
In contrast, Mrs A recalls that in February 2008 Mr A decided
not to have the SIRT treatment because he did not want to have
further treatment from Professor Stubbs and felt he had gone
through enough. She disputes that he was too debilitated for the
SIRT treatment and states that he recovered to some extent. She
believes he was physically able to tolerate the SIRT treatment but
he did not wish to deal with Professor Stubbs again. Mrs A also
disputes Professor Stubbs' comment that he willingly returned the
$15,000 they had paid for the SIRT treatment. She said that the
refund was made only after they were asked by the private hospital
to pay their bill and Mr A said he would not pay until Professor
Stubbs had refunded the SIRT treatment money, which until then he
had failed to do.
Mrs A recalls a telephone conversation in February 2008 where
"Professor Stubbs told me the treatment would have been much more
successful had [Mr A] not had chemotherapy and steroids. Yet this
was not made clear prior to [Mr A] going to [Hospital 2] [for the
surgery]. I do feel we were misled … [Mr A] felt ripped off by the
process, he had every risk factor that indicated the surgery wasn't
advisable yet he was persuaded by Professor Stubbs (and others) and
his inaccurate information to pursue the treatment."
Death
Mr A died two months later.
Complaint
Mrs A complained to HDC about Mr A's treatment at the private
hospital and at Hospital 2. With regard to the treatment provided
by Professor Stubbs, she complained that Mr A was aware of the 65%
success rate of the SIRT treatment but not of the high risks of the
bowel surgery for a person with his risk factors, and that this
information might have made a difference to their decision to
proceed with SIRT. Her husband talked only about the benefits of
the SIRT treatment, and she does not believe that he was made aware
of the risks of the surgery.
Mrs A also complained about the lack of response from Professor
Stubbs to Mr A's deteriorating condition following the surgery and,
in particular, the lack of pain relief provided to her husband. In
addition, they were not given accurate information after the
surgery, as they were told that it had been straightforward and had
gone well, but discovered later that blood replacement was required
for significant blood loss.
Mrs A and her family feel that Professor Stubbs acted
unprofessionally and without real regard for Mr A's quality of
life.
Professor Stubbs' response
Professor Stubbs advised that SIRT has been offered at the
private hospital for over 12 years for the management of advanced
hepatic malignancy, and has been given to well over 200 patients.
The private hospital is the only centre in New Zealand offering
this treatment. He stated, "The treatment options and their value
are fully discussed by me in my patient information booklet which
is given to all prospective patients usually before they see me for
their first consultation."
Professor Stubbs acknowledged that SIRT treatment is more
difficult if major bowel surgery is required as well as treatment
for the liver tumour, and said that "[Mr A] was made aware of the
importance to his treatment program of an uncomplicated course in
relation to his rectal cancer surgery. Regrettably, complications
were encountered; this was unfortunate but the possibility was
foreseen and taken into account."
Professor Stubbs said that while at the private hospital Mr A
was generally seen by members of his medical team twice a day, and
was always seen daily and more frequently if required. Mr A showed
good clinical progress for the first few days after surgery and had
a relatively normal pulse rate, normal temperature, satisfactory
blood pressure, normal respiratory rate and normal urine output. Mr
A became oedematous, which is virtually universally seen in those
undergoing major surgery in the presence of major metastatic
disease and/or nutritional deficiency. Mr A's slow progress was not
entirely unexpected in view of his large burden of metastatic
disease. There were no grounds to believe that an anastomotic leak
with peritonitis had occurred until 17 December, when it was
revealed by the chest X-ray and CT scan.
Professor Stubbs disputed the opinions of my expert advisors, Dr
Johnston and Professor Parry, because he considered they both
wrongly considered that Mr A had a bowel obstruction, whereas he
had an elective bowel resection and underwent elective bowel
preparation the day before surgery. He explained that the comment
in the operation notes that there was "a degree of obstruction"
related the degree of dilatation proximal to the tumour, and did
not mean there was an acute bowel obstruction. He also believed my
experts misunderstood the level in the rectum at which the
anastomosis was performed, and were under the impression it was a
low anterior resection. Professor Stubbs emphasised that the
surgery involved a high anterior resection.
Opinion: Breach - Professor
Stubbs
Mr A was terminally ill and wanted to pursue treatment that had
the potential to extend his life. In such circumstances, a
reasonable patient considering innovative and expensive treatment
needs to be given balanced information about the merits of the
procedure, to enable them to make decisions with their eyes wide
open. As noted by Joanna Manning:[14]
"Patients who are extremely ill or facing terminal or incurable
conditions where the standard treatment is ineffective or has
failed pose particular difficulties in balancing patient autonomy
and protection from harm. Arguably, it may be justifiable to submit
a patient to a greater degree of risk than minimal with fully
informed consent in such circumstances."
When an experimental or innovative procedure is involved,
particular care is required to ensure patients are fully informed
and aware of the risks.
Appropriateness of surgery
In June 2006, Mr A was diagnosed with colorectal cancer
affecting the recto- sigmoid junction. Treatment with chemotherapy
was reasonably successful for 18 months, but the cancer then began
to progress. He was referred to gastroenterology and hepatobiliary
surgeon Richard Stubbs in his private practice for an assessment of
treatment options.
On 18 November 2007, Professor Stubbs had a consultation with Mr
A, who was accompanied by his son-in-law, Mr B. A clinical
examination revealed a grossly enlarged liver from metastatic
disease, and rectal examination and sigmoidoscopy confirmed the
presence of a tumour 12cm from the anal margin.
Mr A indicated that he was keen to pursue any option that might
extend his life. Professor Stubbs explained that SIRT followed by
HAC had a good prospect of controlling the disease in his liver for
a period of time but was not curative. He explained that it would
be necessary to remove Mr A's bowel tumour, as he already showed
symptoms suggesting incipient bowel obstruction.
Professor Stubbs proposed an anterior resection of the rectum to
remove the tumour, with a probable primary anastomosis plus a
cholecystectomy and insertion of a hepatic artery port-a-cath for
the purposes of SIRT and subsequent HAC. He explained that, in his
experience, a good response to SIRT could be expected in
approximately 65% of people in Mr A's circumstances, so long as
there was good recovery from the surgery. He told Mr A there was a
5% chance of an anastomotic leak and that the overall risk of
mortality from the surgery was 1%.
My expert advisor, general and hepatobiliary surgeon Dr
Johnston, advised that the decision to offer surgery was reasonable
in light of Mr A's request for active treatment, although it needed
to be recognised that the treatment proposed was at the very limit
of what could be done surgically for him.
Risk of anastomotic leak
Dr Johnston was concerned that a primary bowel anastomosis was
fashioned in the presence of an apparent bowel obstruction, because
of the risk of leakage. He suggested that HDC seek further expert
advice as to whether this operation was appropriate in Mr A's
circumstances, particularly his degree of obstruction, metastatic
disease and steroid administration.
Further expert advice was obtained from Professor Bryan Parry,
consultant colorectal surgeon, who advised that the risk of
anastomotic leakage in this case was significantly higher than 5%
because of the risk factors, which included Mr A's male gender,
significant comorbidities, liver metastases, high steroid usage,
and obstructed colon. Professor Parry assessed the cumulative odds
ratio of increased risk of an anastomotic leak at over 20%.
Professor Parry acknowledged the divergence of opinion within
current colorectal practice about the pros and cons of a
defunctioning ileostomy[15] and said that, in
light of Mr A's advanced disease, a surgeon might choose not to do
an ileostomy on the grounds of preserving Mr A's quality of life.
However, Professor Parry stated that the patient would have to be
made aware of this and be in full agreement:
"… [T]his would need to have been discussed with the patient
prior to the operation and [Mr A's] informed consent obtained for
either policy. Not doing so would be a departure from appropriate
standard of care of medium severity in my view."
Professor Stubbs responded that the advice provided by Dr
Johnston and Professor Parry was based on incorrect facts, as both
believed Mr A had a bowel obstruction. Professor Stubbs advised
that he recorded in his notes "a degree of obstruction" to refer to
the degree of dilatation proximal to the tumour. This should not be
interpreted as meaning an acute bowel obstruction was present. He
also said there had been a misunderstanding about the level in the
rectum at which an anastomosis was performed. This was a high
anterior resection, not a low anterior resection, and the
anastomosis was above the peritoneal reflection.
HDC sought further expert advice from Professor Parry in light
of this information. He responded that the fact that the rectal
resection was not low meant there was a lesser risk of anastomotic
leaks, but the other risk factors were still operative and were
"summative or cumulative" in their effects on risk. He pointed out
that the operation note had given him new insight that it was a
difficult dissection due to the state of the tissues, perhaps
resulting from previous chemotherapy. Professor Parry considered
that this was a further and independent factor that increased the
risk of a leak and, in his view, added to the case for a
defunctioning loop ileostomy. He referred to the operation notes,
which state that "bowel preparation was imperfect" and that there
was "a degree of obstruction upstream and some dilatation of the
bowel". Professor Parry stated that the additional information did
not change his original conclusions.
Professor Stubbs responded with further explanation of his
reasons for telling Mr A the risk of an anastomotic leak was 5%. He
stated:
"How one can possibly expect to precisely attribute a risk to an
individual patient under these circumstances defies
credibility. This brings me to the question how should estimates of
risk be related to patients, given the impossibility of bringing
any precision to the art. Many doctors, recognising these
limitations, prefer not to nominate specific percentages when they
speak of risk. Those of us who do, do so not in order to indicate
any precision, but rather to demonstrate approximate order of risk.
The point I made to [Mr A] was that he was a higher than usual risk
of a leak, and that if a leak should occur it would be unlikely
that we would be able to proceed with his SIRT, and in that event
he would gain no benefit from his/our efforts. I gave a figure of
around five percent to indicate the risk was greater than usual
(i.e. double). The truth is, patients in his situation do not
decide to proceed or not based on differences of two and five
percent or even five and ten percent, or for that matter ten and
twenty percent … I submit that even had I told him of a 20 percent
(which I simply do not accept applied), he would still have opted
for surgery, hoping for subsequent SIRT."
Professor Stubbs submitted that it is impossible to attribute a
specific risk of a particular outcome to a given individual and
that this is not what patients seek or can expect, as the best that
can be done is to give patients an indication of the nature of the
risks they face and, perhaps, an estimate of their risk. He stated,
"The nominating of a figure is fraught with problems, and dispute
around the figure should not, except in extreme and probably very
obvious circumstances, be a basis for determining the adequacy or
otherwise of the informed consent process."
Professor Stubbs obtained expert advice from colorectal surgeon
Dr Richard Perry regarding the risk of an anastomotic leak. Dr
Perry acknowledged that "estimation of the risk of leakage from a
colorectal anastomosis is not an exact science". He reviewed
published literature and concluded:
"If a quantification of risk is to be given, I do not think
Professor Stubbs erred far from the mark when he described a 5%
risk of anastomotic leak."
However, he qualified this as follows:
"It is very difficult to take a literature based quantum
statistic for risk of anastomotic leakage and apply it to an
individual patient undergoing high anterior resection. There are
aspects of the consent process which are much more important and
helpful to the patient than a fraught analysis of the quantitative
risk of an anastomotic leak."
In response, Professor Parry noted:
"It is problematic for all patients, for all surgeons, for all
operations, for all times because of the essentially stochastic
nature of surgical complications. Nevertheless it is the best we
have and underpins all quality and audit endeavours to optimise
patient outcomes. Nihilism serves no useful purpose except as a
refuge."
Discussion
Professor Stubbs' legal counsel observed, in his letter of
instructions to Dr Perry, that "there is a major philosophical
difference between [HDC], who has a liking for reasonably precise
percentages of risk in assessing warnings to be given when
obtaining informed consent and Professor Stubbs … particularly when
performing the more advanced and rare surgery which he offers
…".
This is to mischaracterise the issue at the heart of the case.
It is not a matter of philosophy but of law. Patients are entitled
to the information that a reasonable patient, in their
circumstances, would expect to receive, including "an explanation
of the options available including an assessment of the expected
risks, side effects, benefits, and costs of each option".[16]
What were Mr A's circumstances in November 2007 when he
consulted Professor Stubbs? He had incurable bowel cancer that had
metastasised into his liver. His oncologist had referred him to
Professor Stubbs at his private practice in another centre, for
consideration of innovative treatment (SIRT and HAC) not available
anywhere else in New Zealand. The treatment was expensive and Mr A
had no health insurance. He was keen to pursue any option that
might extend his life. He needed to have an anterior resection of
the rectum with probable primary anastomosis (plus cholecystectomy
and insertion of a hepatic artery port-a-cath) before the SIRT and
HAC could proceed.
A patient in these circumstances would certainly expect to be
told about any risks that the surgery itself might worsen his
overall condition. I agree with Professor Stubbs' point that
patients do not expect mathematical precision. But there is a major
difference between a 1 in 20 (5%) risk and a 1 in 5 (20%) risk.
I accept that an individual surgeon may choose to disclose his
own track record, eg, "This risk has eventuated for 5 of 100
patients on whom I have performed the operation." But in my view, a
responsible surgeon must (1) contextualise his personal track
record by reference to well recognised, published risk data (eg,
"Other surgeons report that this risk eventuated for 5-20 of 100
patients") and (2) adjust the estimate of risk based on the
individual patient's circumstances.
Dr Perry does not think that Professor Stubbs "erred far from
the mark when he described a 5% risk of anastomotic leak". In
contrast, Professor Parry considers the "minimal 5% risk is much
too low in this case" and estimates that Mr A's risk was in excess
of 20%.
As Professor Stubbs' legal counsel notes, "it is within [the
Commissioner's] remit to decide between differing opinions and
frame [the] final report accordingly".
In my view, Professor Stubbs underestimated the cumulative risk
factors relevant to Mr A's situation, including his male sex, his
high comorbidity because of extensive cancer, his liver metastases,
and his preoperative steroid use (which Dr Perry recognised
probably increased Mr A's risk of anastomotic leak "a little" and
"perhaps by a few percentage points").
Dr Perry noted that the overall risk in published studies
depended on the make-up of the group and questioned whether it was
valid to add these risk estimates cumulatively. But the stepwise
increase in risk referred to by Professor Parry, based on the
Auckland City Hospital experience, was from a baseline risk, not an
overall risk. The baseline low-risk subgroup (0-1 risk factors) had
a risk of 3.1%; the risk increased cumulatively to 14.7% with two
risk factors, and to 33.3% with three risk factors.
Nor do I accept Professor Stubbs' justification that "even had I
hold him of a 20% [risk], he would still have opted for surgery,
hoping for subsequent SIRT". It is no answer to a failure to
provide adequate information to claim that the patient would have
opted for the surgery no matter how high the risk. The patient is
still entitled to the information before making a decision.
Patients in desperate circumstances, who are being encouraged to
undergo innovative procedures, are particularly in need of full
information that does not downplay any risks they face. The "more
advanced and rare" the surgery (to quote Professor Stubbs' legal
counsel), the greater the need to err on the high side when
describing well recognised risks.
Defunctioning ileostomy
Mr B recalls that Professor Stubbs told Mr A that a "bag" was
not recommended in his case, although he cannot recall the reasons
for this. He does not recall any discussion of the pros and cons of
a defunctioning ileostomy or that Mr A was given a choice about it.
Professor Stubbs stated that other surgeons "would not have
particularly advocated a defunctioning ileostomy in Mr A's
circumstance, or been critical of non-use of a stoma". I accept the
view of my expert, Professor Parry, that, in light of divergence of
opinion about the matter, a reasonable patient would expect to be
told about the option of a defunctioning ileostomy, and the effects
that an ileostomy might have on his quality of life, and be given
the opportunity to make a choice in light of that information.
Conclusion
Professor Stubbs went to some lengths to provide Mr A with
information that he considered relevant about treatment options.
However, in my view, in light of Mr A's particular circumstances,
he was entitled to be told that he faced a risk in the order of 20%
of an anastomotic leak, and about the option of a defunctioning
ileostomy. I conclude that Professor Stubbs did not give Mr A
adequate information, and breached Right 6(1)(b) of the Code.
Opinion: No breach - Professor Stubbs
Appropriateness of care
On 4 December 2007, Professor Stubbs performed surgery on Mr A
at the private hospital consisting of anterior resection of the
rectum, a cholecystectomy, and an insertion of a hepatic artery
port-a-cath for SIRT. Mr A's progress for the first few days after
surgery was slow, with abdominal distension and oedema, but no
specific complication.
On 16 December Mr A's condition deteriorated and the private
hospital nurses asked Professor Stubbs to review him. Dr Johnston
considered that the anastomotic leak could have been recognised at
this time rather than on 17 December, if Professor Stubbs had had a
higher level of suspicion. The signs can be subtle in the early
stages, but the risk of leakage was known to be higher because of
Mr A's metastatic disease. Dr Johnston considered that Mr A's
steroid use may have masked the signs of infection. However, he
advised that earlier detection of the leak would probably not have
changed the outcome.
Dr Johnston considered that, in general, the care was
satisfactory. I conclude that Professor Stubbs did not breach the
Code in relation to his standard of care.
Other comment
This is not the first time that Professor Stubbs has breached
the Code by inadequate information disclosure. In two recent cases
he has been reminded by HDC of the need to improve his informed
consent practice. In case 07HDC11318, I stated:[17]
"The test is not what other reasonable surgeons would do, but
rather what a reasonable patient, in the particular patient's
circumstances, would expect to be told.
…
What to a surgeon may seem an acceptable risk may be seen in an
entirely different light by the patient."
Similarly, in case 09HDC00795, I noted:[18]
"On the basis of the information Dr Stubbs provided to them, Mr
and Mrs B opted for oncological treatment, unaware that the
vascular access device could fail and what the medical and
financial consequences of this would be.
…
Information about the possibility of failure of the vascular
access device was information that a reasonable consumer in Mr B's
circumstances would expect to receive, in light of the medical and
financial implications should this occur."
I repeat what I said in case 07HDC11318:[19]
"It is of concern that Dr Stubbs still appears not to appreciate
the legal and ethical requirement of obtaining a patient's fully
informed consent."
The first of these cases (following HDC's breach finding and
referral to the Director of Proceedings) led to Professor Stubbs
being found guilty of professional misconduct by the Health
Practitioners Disciplinary Tribunal (Decision No. 271/Med09/113D,
21 December 2009). HDC's breach finding in the second case was
challenged unsuccessfully by Professor Stubbs in judicial review
proceedings (Stubbs v Health and Disability Commissioner,
High Court Wellington, CIV 2009-485-2146, 8 February 2010, Ronald
Young J).
In my view, there is a public interest in this third adverse
finding from HDC in relation to Professor Stubbs' informed consent
practice being made public. Each of the HDC breach findings is
moderately serious, and they have been made within an 18 month
period. My decision to publicly name Professor Stubbs is therefore
consistent with HDC's Naming Policy.[20]
Accordingly, Professor Stubbs will be named in the version of
this report placed on the HDC website, upon the expiry of the
suppression order preventing publication of his name in the
disciplinary proceedings cited above.
Recommendations
I recommend that Professor Stubbs:
- Apologise to Mrs A for his breach of the Code. This apology is
to be sent to HDC and will be forwarded to Mrs A.
- Review his informed consent practice in light of this
report.
- Advise HDC by 30 April 2010 what steps he is taking to improve
his informed consent practice.
Follow-up actions
- A copy of this report will be sent to the Medical Council of
New Zealand and the private hospital.
- A copy of this report identifying only Professor Stubbs and the
experts who advised on this case will be sent to the DHB.
- A copy of this report with details identifying the parties
removed, except Professor Stubbs and the experts who advised on
this case, will be sent to the Royal Australasian College of
Surgeons and the New Zealand Private Surgical Hospitals Association
and placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.
Addendum
The Director of Proceedings decided to lay a charge of
professional misconduct against Professor Stubbs before the Health
Practitioners Disciplinary Tribunal, which heard the matter in
August 2009.
In a decision dated 21 December 2009 the Tribunal found
Professor Stubbs guilty of professional misconduct and subsequently
imposed the following penalties:
(a) Conditions on Professor Stubbs' practice
including that he undergo:
(i) a mentoring programme to run
for a minimum period of 18 months and a maximum of 3 years; and
(ii) a practice audit;
(b) Censure;
(c) A fine of $20,000; and
(d) 50% of costs of both the Director of Proceedings
and the Tribunal.
Permanent name suppression was declined.
A copy of the Tribunal's decision can be found at
http://www.hpdt.org.nz/Default.aspx?tabid=230
Appendix A
Independent advice to Commissioner - General and
Hepatobiliary Surgeon Dr Peter Johnston
This report is given by Peter Stuart Johnston, MB ChB (1978),
FRACS (1985). I have been asked by the Commissioner to provide
expert advice on this complaint. My background in relation to
evaluating this file is of practice in General and Hepatobiliary
Surgery since 1986, in the last three years this being solely
hepatobiliary, upper gastrointestinal and transplantation surgery.
I have read and agreed to follow the Commissioner's Guidelines for
Independent Advisors.
Information provided to me by the Commissioner
includes:
- Complaint
- Notification letters
- Information from Dr Stubbs
- Information from [the private hospital] including clinical
file, response from Mr Stubbs to HDC, operation
record.
- Information from [Hospital 2] including clinical file and
response from [Hospital 2] management to HDC
[At this stage, Dr Johnston sets out the questions asked by HDC,
which have been omitted as they are repeated in the body of his
report.]
1. Please comment generally on the standard of care provided
to Mr A by Dr Stubbs
[Mr A] was referred to Mr Stubbs from [his home city] after a
course of treatment with chemotherapy for colorectal cancer, with
liver metastases and the primary recto sigmoid tumour in situ. Mr
Stubbs discussed surgery to place an access port for intra hepatic
radiation treatment ("SIRT") and excise the primary tumour. The
risks of this surgery as noted by Mr Stubbs in his discussion with
[Mr A] are in my view quite appropriate. In particular, an
incidence of leakage of 5% from the colo-rectal anastomosis was
discussed. At the time of the operation (4.12.2007), Mr Stubbs
recorded that "there was a degree of obstruction upstream with some
dilatation of the bowel and imperfect bowel preparation".
Postoperative progress was rather slow, with abdominal distension
and oedema which persisted. No specific complication was noted, and
this course was evidently ascribed to the magnitude of the surgery
in the presence of bulky metastatic disease. On 16.12.07, Mr Stubbs
was asked to see [Mr A] by the nurses, the [private hospital] notes
refer to low oxygen saturations, Mrs A in her letter to the HDC
refers to extreme pain, grey colour, and his being cold and clammy.
A chest X-ray to be done the following day was arranged, and a
"full and frank discussion" was held with the family about delaying
the proposed SIRT treatment.
The next day, [Mr A] had further deteriorated, the chest X-ray
showed free intra abdominal gas consistent with perforation of the
GI tract (most likely anastomotic leakage); Mr Stubbs was away that
day and [his colleague] became involved and transferred [Mr A] to
[Hospital 2] for urgent surgery. Anastomotic breakdown was
discovered and the bowel anastomosis converted to a stoma.
I believe that in general the care provided at [the private
hospital] was satisfactory, with two reservations. [Mrs A]
questions the responsibilities of the nursing staff when a patient
is not making the expected progress, noting that it was she who
alerted the nurses to call Mr Stubbs on 16.12.07. It is noted that
Mr Stubbs had been in touch by phone the morning of that day. Other
than the low oxygen saturation, which was obvious although of many
possible causes, the clinical situation was evidently not clear
enough to alert Mr Stubbs to a major problem when he reviewed [Mr
A] at 1600 that day; an experienced nurse will sometimes spot a
problem before medical staff notice it, but not necessarily so. I
do not think the nursing staff were at fault here.
The first reservation about the [private hospital] care which
arises is that the anastomotic leakage problem could perhaps have
been recognised on 16.12.07 if a higher level of suspicion had been
present. Admittedly the signs of this can be very subtle at first,
but in this situation the risk of leakage was known to be higher
because of the metastatic disease. Not referred to in Mr Stubbs'
commentary is the steroid drug use: it is well known that the usual
features of infection such as fever and elevation of the white
blood cell count are often masked by steroid drugs. The oxygen
desaturation, combined with the slow progress against this
background could have been viewed with more suspicion, and more
urgent investigation carried out on that day. The outcome would
probably not have been different, however, and it is difficult to
be certain that earlier recognition was possible.
Related to this is my second reservation, that a primary bowel
anastomosis was fashioned in the presence of apparently obstructed
bowel, with the additional risk factors noted above. Anastomosis in
the presence of obstructed bowel is known to have a higher leakage
rate; this problem (or at least its severity) can be averted by
adding a protective ileostomy upstream of the join, or an on-table
washout of the colon to reduce the faecal load if leakage did
occur, or both. Practice in colorectal surgery changes over time
and as I no longer practise regularly in the area of colorectal
surgery I would suggest the Commissioner requests an opinion of a
colorectal surgeon on this specific point, i.e. was a primary
anastomosis of the bowel without covering stoma an appropriate
operation in [Mr A's] circumstances, noting the degree of
obstruction, metastatic disease and steroid administration.
2. If not commented on above, please comment specifically on
the management decisions made by Dr Stubbs
The decision to offer surgery was reasonable in light of the
patient's strong request for active treatment, although it needed
to be recognised that the treatment proposed was at the very limit
of what could be done surgically for [Mr A]. It appears that Mr
Stubbs' discussion of the risks and benefits was realistic. The
other important management decisions have been discussed above,
namely the details of the operation and the recognition of the
anastomotic leak.
Another, more general comment can be made on Mr Stubbs'
response. He extends his commentary to include the role of
palliative care services in patients undergoing cancer surgery. It
appears he was not asked specifically to comment on this, but does
so in discussion of the whole complaint which includes the role of
palliative care. Although there was not a clear role for palliative
care services to assist [Mr A] and his family at [the private
hospital], Mr Stubbs' comments do give rise to concern. He states
that discrepancies in approach between the surgical and palliative
care philosophies may give rise to "distress and confusion in the
minds of the patients and their families", and for this reason
tries to avoid combining the two approaches. I think this is an
extreme view in 2008; I believe that while a conflict in approach
may arise, this is a necessary conflict, with which the patient and
family need to engage. The input of an experienced clinician who
does not have a subconscious attachment to the success of the
surgery can be invaluable in management decisions, and to deny this
input, if applied as a regular practice, would deny some patients
access to appropriate options. As stated above, I do not think this
was the case in [Mr A's] stay at [the private hospital].
3. Please comment generally on the standard of care provided
to Mr A by staff of the private hospital
I have touched on this above, and regard the care as
satisfactory.
[This section has been excised because it relates to a provider
who is not the subject of this investigation.]
Appendix B
Independent advice to Commissioner - Consultant
Colorectal Surgeon Professor Bryan Parry
Initial advice
I am Bryan Ronald Parry, Professor of Surgery at the University
of Auckland and a Consultant Colorectal Surgeon at Auckland City
Hospital. I am vocationally registered with the New Zealand Medical
Council, No. 7011, and am a Fellow of the Royal Australasian
College of Surgeons as well as a member of the Colorectal Surgical
Society of Australia and New Zealand. I am a practising colorectal
surgeon with a strong general surgical background, and am the
Clinical Director of the Nutrition Support Service at the Auckland
City Hospital.
I acknowledge the receipt of photocopies of clinical notes of
[Mr A's] stay at [the private hospital] and subsequently during the
time of his stay at [Hospital 2]. In addition I have received a
copy of a report [from Hospital 2] in response to a request by Rae
Lamb the Deputy Commissioner of HDC. Furthermore I have a copy of
Mrs A's original letter to the Health and Disability Commissioner
of 24 June 2008 with her complaint as well as two letters from Dr
Richard Stubbs answering the queries requested by the Deputy
Commissioner of HDC.
Pertinent to your request of me, I have an extract of the report
previously requested by yourself of Dr Peter Johnston highlighting
the key issue for which you require my advice:
Whether it would have been appropriate for Dr Stubbs to have
done a defunctioning loop ileostomy at the time of operating on the
4 December 2007 to either reduce the chance of anastomotic leakage
or make it less risky to the patient's condition if it had
occurred.
Dr Peter Johnston points out that:
"A primary bowel anastomosis was fashioned in the presence of
apparently obstructed bowel, with additional risk factors noted
above. An anastomosis in the presence of obstructive bowel is known
to have a higher leakage rate; this problem (or its severity) can
be averted by adding a protective ileostomy upstream of the join,
or an on-table washout of the colon to reduce the faecal load if
leakage did occur, or both. Practice in colorectal surgery changes
over time and as I no longer practise regularly in the area of
colorectal surgery I would suggest the Commissioner requests an
opinion of a colorectal surgeon on this specific point, i.e. was a
primary anastomosis of the bowel without covering stoma an
appropriate operation in the patient's circumstances, noting the
degree of obstruction, metastatic disease and steroid
administration."
I will attempt to answer this question under the following
headings:
Risk factors for anastomotic leaks
The following risk factors for anastomotic leakage after
colorectal anastomosis have been recognized by various authors:
male gender[21], previous abdominal surgery[22], low rectal anastomosis[23], liver metastases[24], preoperative radiation[25], occurrence of intra-operative technical
surgical problems[26], preoperative steroid
use[27], long duration of operation[28], contamination of the operative field[29], and patient high ASA score (measure of co
morbidity)[30].
These data provide a framework in which to consider [Mr A's]
case. He was male gender, had high co morbidity because of his
extensive cancer, had liver metastases, had preoperative steroid
use, as well as having undergone a long operation. I note that
blood loss was estimated to be approximately 800ml - which is quite
high for this sort of operation and therefore I wonder whether
intra operative difficulties were encountered accordingly but not
annotated.
Additionally this man had an obstructed colon - an additional
factor not addressed by the above literature series as all of them
were in the elective setting.
Leak rates in rectal anastomosis
The Auckland Hospital experience revealed an overall leak rate
of 7.4% for colorectal anastomosis but the incidence went up
stepwise according to the number of risk factors present. In our
particular study these were male gender, previous surgery, low
anastomosis, and inflammatory bowel disease diagnosis. However this
stepwise escalation of leak rate would apply to the other papers
quoted above.
Therefore a risk of anastomotic leak rate of 5% as quoted to [Mr
A] by Dr Stubbs was, in his circumstance, likely to be too low in
my opinion.
Does defunctioning loop ileostomy help?
Matthiessen et al in their randomised control trial of using
defunctioning ileostomy found no difference in preventing a leak
with a use of temporary stoma per se. Nevertheless Chude et al
showed both a reduced incidence of anastomotic leak and a better
outcome for those patients in which a defunctioning ileostomy was
made.
In my view I think a defunctioning loop ileostomy would have
been helpful in reducing the impact of an anastomotic leak in this
ill patient, and might have reduced its likelihood too. Certainly
that would have been the approach taken with this patient in the
Colorectal Unit at Auckland City Hospital based on our own data
alluded to above.
It has to be said for the sake of balance however that, on a
case-by-case basis, the surgeon may choose not to do a loop
ileostomy (the risk notwithstanding) in someone like [Mr A] with
advanced disease on quality of life (QoL) grounds. A stoma would
reduce the QoL in the remaining (short) time of the patient's life
expectancy. The patient would have to be made aware of this and be
in full agreement however. I am not aware this was done in [Mr A's]
case: Dr Stubbs' admission note for [Mr A] on 3 December contains
no mention of preoperative stoma siting in preoperative preparation
order list.
Summary
1. The risk of anastomotic leakage in this man was significantly
higher than 5% in this man's case because of his risk factors
including male gender, significant comorbidities, liver metastases,
high steroid usage, and an obstructed colon. Extrapolating from the
quoted studies, his cumulative odds ratio of increased risk of
anastomotic leak would conservatively make it in excess of 20%.
2. A defunctioning ileostomy was advisable and might have
reduced the impact of the leaked anastomosis on [Mr A's] clinical
course.
3. Despite the evidence cited, there is a divergence of opinion
within current colorectal practice about the pros and cons of
defunctioning ileostomy. However this would need to have been
discussed with the patient prior to the operation and [Mr A's]
informed consent obtained for either policy. Not doing so would be
a departure from an appropriate standard of care of medium severity
in my view.
Further advice
Thank you for inviting me to consider my advice in the light of
the three documents enclosed in your letter of 30 June 2009:
- Letter Professor Stubbs 26 Mar 2009
- Professor Stubbs' Operation Note 04 Dec 2007
1. The operation note clarifies for me that the rectal resection
was "high" (or at least "mid") and not "low". I agree the level of
resection here has a lesser risk of anastomotic leak than when
situated "low" per se, but the other risk factors were still
operating, and these are summative or cumulative on their effect on
risk.
2. The operation note also provides new insight that it was a
difficult dissection due to the state of the tissues perhaps
resulting from previous chemotherapy. This is a further and
independent factor in increasing the risk of leak, in my view, and
adds to the case for a defunctioning loop ileostomy here.
3. Furthermore the operation note clearly states that the "bowel
preparation was imperfect" and that there was "a degree of
obstruction upstream and some dilatation of the bowel".
4. The discursive content of Professor Stubbs' letter regarding
leak rate risks was addressed in my earlier report supported by key
literature. In summary, independent risk factors are summative or
cumulative in their effect, therefore the nominal 5% risk is much
too low in this case.
5. My three conclusions set out at the end of my report dated 14
Jan 2009 remain my assessment of this case.
Appendix C
Expert advice provided by Dr Richard Perry to Professor
Stubbs
My name is Richard Edward Perry, MBChB, DipObs, FRACS. I am a
New Zealand registered Medical Practitioner and vocationally
registered General Surgeon. I studied at the University of Otago
Medical School, trained in General Surgery in Christchurch, and
specialised in colorectal surgery at Creighton University in Omaha
Nebraska and at the Mayo Clinic in Rochester Minnesota, USA. For
the past 19 years, I have been in private practice as a Colorectal
and Endoscopic Surgeon in Christchurch where I am currently
Director of Intus Ltd Gastrointestinal Health at the Oxford Clinic.
I am Chairman of the Australian & New Zealand Surgical Skills
Education and Training Committee of the Royal Australasian College
of Surgeons, and I was a member of the Council of the Colorectal
Surgical Society of Australia and New Zealand for 9 years until
2008.
This opinion relates only to the single aspect requested: the
content of Professor Parry's summary paragraph 1 which led to HDC
criticising the consent process followed by Professor Stubbs.
This paragraph states:
"The risk of anastomotic leakage in this man was significantly
higher than 5% in this man's case because of his risk factors
including male gender, significant comorbidities, liver metastases,
high steroid usage, and an obstructed colon. Extrapolating from the
quoted studies, his cumulative odds ratio of increased risk of
anastomotic leak would conservatively make it in excess of
20%."
I do not have the full report of the Health and Disability
Commissioner, and I have been provided with limited correspondence
upon which this opinion is based:
- A letter of request from Professor Stubbs' lawyer.
- A letter from HDC to Professor Stubbs, dated 18 February 2009,
advising of his decision to refer him to the MCNZ
- Report from Professor Stubbs about [Mr A] dated 30 October
2008
- Report by Peter Stuart Johnston dated 10 December 2008
- Report from Professor Bryan Parry dated 6 January 2009
- Letter from Professor Stubbs to HDC dated 26 March 2009
- Further letter from Professor Parry to HDC dated 29 July
2009
- A copy of the original Operation note dated 4 December
2007
At the core of the issue under scrutiny are three questions:
1. What is the risk of anastomotic leakage (leak from the join
between two ends of bowel) after high anterior resection of the
rectum?
2. What was the risk of anastomotic leakage following this
operation on [Mr A]?
3. How should this risk best be conveyed to the patient during
the consent process?
1. What was the risk of an anastomotic leak after high
anterior resection of the rectum?
1.1. [Mr A] had a "high anterior resection". This
means a "high" anastomosis was created between the colon and the
rectum, in the abdominal cavity ("above the peritoneal reflection")
and between 10cm and 15cm above the anus.
1.1. Estimation of the risk of leakage from a
colorectal anastomosis is not an exact science.
1.2. In a recent (2007) publication of his own
data, Australian colorectal surgeon Professor Cameron Platell
stated that "it is surprisingly difficult to obtain current and
accurate data on anastomotic leak rates from the
literature".1
1.3. Two key factors in anastomotic leak are:
1.3.1. Skill and experience of the Surgeon. A landmark
study demonstrated a variation in anastomotic leak rates from 0% to
25% among surgeons.2
1.3.2. Distance of the anastomosis from the anus. Low
anastomoses have a higher risk of leaking.
1.4. Leak rate statistics are derived from a
surgeon's personal audit and/or from published case series:
analysis of tens or hundreds of similar (but not identical) cases.
Figures vary widely due to variations in patient population and
case-mix, experience and specialisation of surgeon and surgical
staff, institutional and environmental factors, the location of the
anastomosis, evolution and improvements in surgical and
perioperative management techniques (which have been significant
over the past decade).
1.4.1. For example, of Parry's Auckland Hospital series
of 160 patients undergoing anterior resection between 1992 and
2002, 9% had an anastomotic leak.3 This is a teaching
hospital environment where the operating surgeon may be a trainee,
or may not be a specialist colorectal or gastrointestinal
surgeon.
1.4.1.1. When this figure was refined according to
location of anastomosis, the rates were 7.6% for a low (<5cm
from anus) anastomosis, 4% for mid (6-10cm from anus) and 14% for
high (10-15cm) anastomoses. [Mr A's] anastomosis was high, so at
first glance at Parry's figures, one might anticipate a 14% risk of
anastomosis, had he undergone his operation at Auckland Hospital
between 1992 and 2002. However this would not be an accurate
estimate because of the patient case-mix. Further review of Parry's
figures reveals that the higher leak rate in the high anterior
resection group was due to the high proportion of those patients
who had diverticular disease: their leak rate was 26% compared with
5% for cancer patients (p=0.004). In other words, they had a
different underlying disease process and different indication for
the operation.
1.4.1.2. Furthermore, the leak rate after high anterior
resection was 19% when the inferior mesenteric artery was ligated
high (which is done for some cancer cases but not for diverticular
disease), and 5% when it was ligated low (p=0.02). The latter group
is likely to have included most or all of the diverticular disease
patients, so the leak rate for patients (such as [Mr A]) with low
ligation and high anastomosis for cancer was probably a lot less
than 5%. Such is the complexity that the exact rate in this series
cannot be extracted from the data given.
1.4.1.2.1. This range of figures from Parry's study alone
illustrates the difficulty in quantifying an exact percentage risk
of anastomotic leak in an individual patient. There are too many
confounding variables.
1.4.2. Another, similar study from Europe looking only at
cancer cases had a 4% incidence of anastomotic leak for high
anterior resection, 11% for mid, and 24% for low anterior
resection.4
1.4.3. A prospectively collected personal series
published recently of 243 anterior resections performed by two
specialist colorectal surgeons showed an overall leak rate for all
levels of colorectal anastomosis of 2.5%.5
1.4.4. Professor Platell's series from an Australian
colorectal surgical unit had anastomotic leaks in 2.3% of high
anterior resections for cancer (vs 7% for low anterior
resection).1
1.4.5. A recent large series from Shanghai had a 0.9%
leak rate for high anterior resection (vs 5.9% for low
anastomosis). Bowel surgeons performed significantly better than
General surgeons (3.9% vs 11.3% leak rate over all levels of
anastomosis).6
1.5. In Summary, in experienced
hands, there is good, recent evidence that the anastomotic leak
rate should be between 0.9% and 5% for a cohort of patients
undergoing the same operation as [Mr A]. Note that there is an
order of magnitude of difference between these figures.
2. What was the risk of anastomotic leakage following
this operation on [Mr A]?
2.1. It is important to note that all the above
series contain a heterogeneous group of patients. Individually,
they will all have had their own risk factors. The 0.9 to 5%
statistic includes all of these risk factors in all of these
patients.
2.2. It is common practice to attempt to refine the
risk estimate for an individual patient based on their unique
risks. It is not valid to add these risk estimates cumulatively to
the group statistic described in paragraph 1. The more frequently
the risk factor occurs, the more reliably it will have been already
accounted for in the group statistic. The less frequently it
occurs, the less accurate the unique risk statistic will be.
2.3. There are factors, in addition to those
outlined above, which are more likely to be present in patients who
develop an anastomotic leak. It would be almost impossible to
classify and study enough patients to resolve the quantum of risk
directly attributable to each of these factors.
2.4. There is almost universal agreement that the
following factors are statistically significantly associated with
anastomotic leakage: male gender, diabetes, cigarette smoking, low
pre-operative albumin, prolonged operation, and excessive
intraoperative blood loss.
2.5. I will deal with two other risk factors
separately because they were raised by Professor Parry:
2.5.1. Acute colonic obstruction is a
risk factor for anastomotic leakage. However, this risk factor was
identified in patients presenting with acute fulminant colonic
obstruction requiring emergency operation. In this situation an
anastomotic leak is more likely to occur because the patient has
many additional compromising factors, including fluid and
electrolyte imbalance, impaired colonic perfusion, and gross
colonic distension causing inflammation. [Mr A] did not have an
acute colonic obstruction and I do not consider that the reference
made in the operation note describes clinically significant
obstruction that would significantly increase the risk of
anastomotic leak.
2.5.2. Preoperative steroid use has been
identified as a risk factor because steroids impair wound
healing.
2.5.2.1. As difficult as it is to put a meaningful figure on the
general risk of anastomotic leak, it is even more difficult to
ascribe a quantitative risk increment to the use of steroids.
2.5.2.2. The duration of steroid therapy and the dose received
over the few days prior to the operation are probably also
important factors.
2.5.2.3. Steroid use appears inconsistently in the list of risk
factors in published studies. Steroid use is generally a marker of
another underlying disease process. In many cases, it is these
processes (rather than or in addition to the steroids per se) that
contribute to the additional risk of anastomotic leak.
2.5.2.4. This is well illustrated in two excellent recent papers
from USA and from France, where the authors set out to try to
refine our understanding of the risks of anastomotic leakage. In
their univariate (single factor) analysis, both studies showed an
increased risk of anastomotic leak in patients on steroids.
However, this increased risk did not persist on multivariate
analysis, which allowed for the underlying conditions being treated
with steroids, such as inflammatory bowel disease. These conditions
are therefore at least as relevant as steroid use itself when
assessing the risk from steroid use.7,8
2.6. In Summary, [Mr A's] risk of
anastomotic leak was probably a little increased by his
preoperative steroids, but there is no data upon which this can be
quantified. From the description of the obstructive element in the
operation note, I do not think it materially affected the risk of
anastomotic leak.
3. How should the risk of anastomotic leak best be
conveyed to the patient during the consent process?
3.1. Leak rate figures describe a statistical risk:
What they say is that if 1000 patients have a high anterior
resection, it is very likely that between 9 and 50 of them will
develop an anastomotic leak.
3.1.1. Each one of those 1000 patients will have other
factors that may influence the outcome of the operation for them.
The impact of these factors cannot be quantified.
3.1.2. Surgical expertise is a factor too.
3.1.3. Therefore, it is very difficult to assign an
accurate numeric value to the risk in any individual patient. The
most meaningful statistic would come from the surgeon's personal
experience. This is particularly so when the surgeon is highly
specialised, so that his patient series will be sufficiently large
and more homogeneous with regard to other risk factors than would
be a series from a less specialised unit or from a teaching
hospital.
3.2. It is reasonable, and common practice in
obtaining informed consent, to try to give a patient a tangible
concept of their risk of an anastomotic leak (amongst other
things). The best a surgeon can do in that regard is to offer that
by his estimate and experience, when he performs the operation in
question on 100 patients, a few will leak (say 2-5). He might
estimate that due to steroid use or other comorbidities, the
likelihood of a leak is increased, perhaps by a few percentage
points. Ultimately, we do not really know how much more likely any
individual is to leak because they are on steroids, and we don't
know whether that particular patient will be the unlucky one.
3.3. The heterogeneous basis from which the
anastomotic leak rate statistics are derived make it a nonsense to
argue about variations in relative risk of a few percentage points,
or even of a low order multiple. Leak rate data can do no more than
give a rough guide as to the order of magnitude of a risk.
3.4. In Summary, it is very
difficult to take a literature based quantum statistic for risk of
anastomotic leakage and apply it to an individual patient
undergoing high anterior resection. There are aspects of the
consent process which are much more important and helpful to the
patient than a fraught analysis of the quantitative risk of
anastomotic leak. If a quantification of risk is to be given, I do
not think that Professor Stubbs erred far from the mark when he
described a 5% risk of anastomotic leak. There is no scientific
basis upon which the cumulative risk from [Mr A's] comorbidities
can be extrapolated to a 20% risk of anastomotic leak.
References
1. Platell C, Barwood N, Dorfmann G et al. The
incidence of anastomotic leaks in patient undergoing colorectal
surgery. Colorectal Dis 2007; 9:71-7.
2. McArdle CS, Hole D. Impact of variability
among surgeons on postoperative morbidity and mortality and
ultimate survival. BMJ 1991; 302: 1501-5.
3. Abbas SM, Parry BR. Anastomotic leak following
high anterior resection and diverticular disease as a risk factor.
Surgery Journal 2006; 1(1):26-8.
4. Rudinskaité G, Tamelis A, Saladžinskas Z,
Pavalkis D. Risk factors for clinical anastomotic leakage following
the resection of sigmoid and rectal cancer. Medicina (Kaunas) 2005;
41(9) 741.
5. Hyman N, Manchester TL, Osler T, Burns B,
Caltado P. Anastomotic leaks after intestinal anastomosis: It's
later than you think. Ann Surg 2007;245(2),254-58.
6. Cong Z-J, Fu C-G, Wang H-T, Liu L-J, Zhang
W, Wang H. Influencing Factors of Symptomatic Anastomotic Leakage
After Anterior Resection of the Rectum for Cancer. World Journal of
Surgery 2009;33(6),1292-7.
7. Suding P, Jensen E, Abramson MA, Itani K, Wilson
SE. Definitive Risk Factors for Anastomotic Leaks in Elective Open
Colorectal Resection. Arch Surg 2008;143(9):907-912.
8. Alves A, Panis Y, Trancart D et al. Factors
associated with clinically significant anastomotic leakage after
large bowel resection: multivariate analysis of 707 patients. World
J Surg 2002; 26:499-502."
Appendix D
Further independent advice to Commissioner
-
Consultant Colorectal Surgeon Professor Bryan
Parry
Thanks for your invitation to comment on this ongoing file. I
acknowledge the attached documents from [Professor Stubbs' lawyer]
and Richard Perry both of which I have considered.
- Richard has provided information gleaned from the published
literature of risk of anastomotic leak (AL) after anterior
resection. In brief, he argues that the application of statistical
risk of AL from diverse reports of heterogeneous groups of patients
to that of an individual patient such as [Mr A] is problematic.
However, it is problematic for all patients, for all surgeons, for
all operations, for all times because of the essentially stochastic
nature of surgical complications. Nevertheless it is the best we
have and underpins all quality and audit endeavours to optimize
patient outcomes. Nihilism serves no useful purpose except as a
refuge.
- He contradicts my assessment of AL in [Mr A's] case by
selecting a different set of papers than mine. Fair enough, and
theoretical discussion needs to be open and comprehensive. However
the study from Auckland in which I took part is arguably closer to
the environment in which [Mr A] underwent surgery than elsewhere
particularly overseas. I therefore have confidence in the rigour of
our study and its applicability to his case.
- Richard has overlooked that risk factors are derived from
studied independent variables revealed by multiple regression
analysis. The independent variables or risk factors are
additive and ramp up any particular individual's risk of
AL alarmingly if he/she has multiple co-morbidities. That is why my
estimate is 4 times higher than his in [Mr A's] case.
Turning to the nub. If, at the regular Audit Morbidity and
Mortality Meeting in my institution my colleagues sought
explanations of me about such a case, I would expect an
uncomfortable time. Not to have done, or at least discussed, a
defunctioning stoma with the patient would likely be received with
surprise and even incredulity. It would be regarded with moderate
opprobrium.
In fairness, as I said in a previous submission, not to do a
temporary stoma is an option when considering quality of
life issues in terminal patients when the risk might be deemed
worthwhile. However the patient's informed views are paramount and
the discussion needs to be had.
My opinion remains unchanged.
[1] Secondary cancers.
[2] In due course, Professor Stubbs
submitted expert advice only from Dr Richard Perry.
[3] Treatment with anti-cancer drugs
that are injected into a vein or muscle, or are taken orally. These
drugs enter the bloodstream and reach all areas of the body. They
can destroy not only the cancer cells but also affect healthy
cells.
[4] Dexamethasone is a
corticosteroid.
[5] Sigmoidoscopy is the medical examination of the large intestine from the rectum through the last part of the colon.
[6] The anal canal goes from the rectum
to the anal margin where the canal meets the outside skin
at the anus.
[7] The surgical removal of the gall
bladder.
[8] A "port-a-cath" is an access port
introduced under the skin over the right lower rib cage. "The port
is attached to a fine catheter or tube which is placed in the
hepatic artery as it goes into the liver. The port is either used
each month for chemotherapy or it needs to be flushed, to stop it
clotting off, which would mean it could no longer be used. Even if
the port is no longer being used there is usually no need for it to
be removed." Ref: "Liver Cancer: A Guide to Diagnosis and
Treatment." Richard S Stubbs, August 2007, p 24.
[9] The microspheres become trapped in
small blood vessels feeding the tumour and remain radioactive for a
total of three weeks. The microspheres are specially prepared for
the patient in a nuclear reactor in Sydney, Australia, and
despatched to the private hospital. The microspheres must be
ordered eight days before delivery, because their half-life is 2.6
days, and there is little opportunity to delay upon delivery
without the dose falling to levels that make it less useful.
[10] An artery that distributes blood
to the liver, pancreas and gall bladder as well as to the stomach
and duodenal portion of the small intestine.
[11] Excessive
accumulation of fluid in the
body tissues.
[12] Wind.
[13] A pneumoperitoneum is air or gas
in the abdominal (peritoneal) cavity.
[14] Manning J, "Determining Breach of
the Standard of Care" in Skegg & Paterson (eds), Medical
Law in New Zealand (Brookers, Wellington, 2006) ch 4, p
139.
[15] A defunctioning ileostomy is a
surgically created opening of a loop of terminal ileum brought up
through the surface of the skin, usually in the right iliac fossa.
The stoma will divert faecal waste away from the anastomotic
site.
[16] Right 6(1)(b) of the Code of
Health and Disability Services Consumers' Rights.
[17] 07HDC11318 (17 October 2008) at
page 32.
[18] 09HDC00795 (15 September 2009) at
page 11.
[19] At page 38.
[20] "Policy
Document - Naming Providers in Public HDC Reports", Health and
Disability Commissioner, 15 July 2008, accessible at /
[21] Lipska et
al, ANZJ.Surg 2006, 76:579-85; Matthiessen et al, Colorectal Dis.
2004:462-9.
[22] Lipska et al, ANZJ.Surg 2006,
76:579-85.
[23] Lipska et
al, ANZJ.Surg 2006, 76:579-85; Matthiessen et al, Colorectal Dis.
2004:462-9; Buchs et al, lnt J Col Dis 2008 23:265-70.
[24] Lipska et al, ANZJ.Surg 2006,
76:579-85.
[25]
Matthiessen et al, Colorectal Dis. 2004:462-9.
[26] Matthiessen et al, Colorectal Dis.
2004:462-9.
[27] Konishi et al JM Col Surg 2006
202:439-44.
[28] Konishi et al JM Col Surg 2006
202:439-44; Buchs et al, lnt J Col Dis 2008 23:265-70.
[29] Konishi et al JM Col Surg 2006
202:439-44.
[30] Buchs et al, lnt J Col Dis 2008
23:265-70.