Review of ACC Decision - Christine Sheehan

The Claim

As a result of the treatment injury that culminated in a perineal hernia, Christine required a corrective surgery.

The time off required for that surgery, the stay in hospital and subsequent post-operative recovery amounted to five full weeks from the date of the surgery (12 January, 2015) until return to work (15 February, 2015). In addition, Christine recommenced work on reduced duties of three shifts a week out of the normal four because she wasn’t up to doing more. The three shifts a week continued until she resumed four shifts in the week beginning 24 August, 2015.

This amounts to 5 weeks at four days and 30 weeks at one day, total 50 days of lost pay in annual leave, sick days and just time off without pay.

There is still evidence of inadequate repair of the hernia which will possibly mean further surgery and time off work.

Christine’s surgeon has stated that the injury is not an ordinary consequence of this type of surgery - and this should be good enough - the case should have been settled at that point. However, the ACC have employed a medical advisor, to go to great lengths in order to contradict the attending surgeon.

I will show, that the ACC have deliberately misrepresented the main, and in effect, only study they put up against the claim, in order to deprive their ‘client’, Christine, of what should be a lawful and appropriate entitlement to help her through these difficult and stressful times.

I cannot bear to imagine how many other people have been robbed of aid they should have received by such tactics as I’ve uncovered in the course of this review.

A Word About Observational Studies

Much of the literature referred to in the decision are observational studies. In no way can they show a correlation or association implying causation. When chemoradiotherapy, for example, is identified as a risk factor, it is acceptable to say that it may, or could, increase the risk, but it is not acceptable to say that it would, or did, increase the risk.

The Treatment Injury

According to the attending surgeon, David Vernon:

“Perineal herniation occurs in approximately 1-3% of patients undergoing abdominoperineal excision of the rectum”

“To the extent that Christine would not have developed a perineal hernia if she had not had rectal cancer surgery, then there is no doubt that the surgery was primarily responsible for this incident. It is not however an inevitable consequence of the operation, at least in the perineum.”

The surgeon is saying that the injury is a result of the surgery and that it is not an ‘ordinary’ development of this type of surgery.

Opinion by the ACC medical advisor:

“Mrs Sheehan presented with perineal and stomal incisional hernias some months following AP resection for rectal carcinoma on 17/03/14.  

A claim has been lodged with ACC for treatment injury in relation to the perineal hernia.

Risk factors for the development of the perineal hernia that can be identified include preoperative chemo/radiotherapy and postoperative radiotherapy –which may adversely affect tissue healing –this along with aggressive surgery removing the pelvic muscular diaphragm along with the rectum to reduce local recurrence rates - technique called an ELAPE (extra levator abdominoperineal excision).

 

And the early development of significant multiple hernias (stomal as well as perineal) is suggestive of a factor in common at both sites such as increased BMI for example - or in particular, a degree of underlying connective tissue deficiency –now known to be increasingly significant as factor also influencing postoperative healing adversely and thus leading to the development of hernias.

There is a lack of information regarding underlying health conditions -in particular BMI –increased BMI an important factor in the subsequent development of incisional hernia.

And there is a lack of information regarding postoperative follow-up after discharge from hospital including information regarding postoperative radiotherapy –and a lack of information surrounding initial presentation to GP with symptoms in relation to development/presentation of the hernias.”

Risk factors were listed that are irrelevant to this case and, because they were left in the notes, may lend undue weight to the overall opinion and decision. These should be discounted in the review process.

Specifically:

“postoperative radiotherapy” 

There was no postoperative radiotherapy in this case. There was one session only of postoperative chemotherapy but Christine decided to terminate that treatment.

“And the early development of significant multiple hernias (stomal as well as perineal) is suggestive of a factor in common at both sites such as increased BMI for example - or in particular, a degree of underlying connective tissue deficiency - now known to be increasingly significant as factor [sic] influencing postoperative healing adversely and thus leading to the development of hernias. [1]**  

There is lack of information regarding underlying health conditions - in particular BMI - increased BMI an important factor in the subsequent development of incisional hernia”

The ACC representative is placing quite a bit of emphasis here on ‘increased BMI’ - so much so that they’ve used the term three times in the two sentences. While it may be seen that Christine’s weight has been recorded in the documents as 77 kg - she has not, at any time during the last 18 months exceeded 71 kg. I suspect that the ‘77 kg’ is perhaps either a misrecording or a transposition of an earlier recording (she was 77 kg prior to diagnosis of adenocarcinoma, but lost weight during the treatment), and in any case would not suggest ‘an increased BMI’ in a subject of 168cm in height. Rather, her condition through this period, was of stable or reducing BMI.

The inclusion of this irrelevant and unproven ‘risk factor’ material smacks of an attempt to cast a negative light on the situation in order to lend weight to the final decision. (Otherwise why leave it in?)

As the ACC medical advisor points out:

“The legislative requirements for cover as a treatment injury are personal injury (the gap in the fascia with hernia) caused by treatment (the

surgery), the injury (hernia) not an ordinary consequence of the surgery.”

That it is a personal injury is not challenged, (the gap in the fascia with hernia), nor is it in debate that it was caused by treatment (the surgery). What ACC appear to be disputing is that the injury is not an ‘ordinary consequence’ of the surgery.

From the Treatment Injury cover decision tool (ACC form 2184)

  1. Part B - acknowledged that a physical injury was suffered
  2. Part D - acknowledged that the personal injury was caused by treatment
  3. Part F - was declined on the criteria that the injury was an ordinary consequence of treatment.

McEnteer Vs ACC (2008) - Hamilton District Court (“105-2008 McEnteer.pdf,” n.d.)

Judge J Cadenhead held that:

“Accordingly the term “ordinary” should be interpreted along the lines of its common meaning - normal, expected, usual or anticipated.”

also:

“[31] If the appellant can show that he suffered an injury caused by treatment and that injury was not a necessary part or ordinary consequence of that treatment then the respondent can escape liability by proving that the personal injury is wholly or substantially caused by a person’s underlying health condition. In my view, the onus on this issue is upon the respondent. This qualification to liability will cause problems, because most medical treatment arises from an underlying condition. Similarly, difficulties of concurrent causation may arise, where both the underlying condition and the treatment combine to produce a personal injury.” (Appellant emphasis added)

ACC have challenged the surgeon’s data that suggests herniation is only evident in 1-3% of such cases. In order to dispute this point and prove that the injury is an ordinary consequence of the surgery, ACC have referred to a small study of 56 (reduced to 54 because of incomplete data on two) patients, published well after Christine’s surgery took place. While it may be argued that this study has little statistical significance in the overall picture of abdominoperineal resections, we should nevertheless have a closer look at what it has found, particularly since ACC have claimed “45%” in their notes to the original decision, and “nearly half”, in their review submission, as being the relative incidence of perineal hernia following ELAPE.

From the notes provided by the ACC advisor, (taken from the abstract of the study):
Of the 56 patients that underwent the ELAPE procedure, only 24 of them developed a perineal wound complication.
Note, it doesn’t specify that the ‘complication’ was a hernia. It does however say that eight of the patients had their primary perineal closure performed with the insertion of mesh or myocutaneous flap and 32 without. Nothing mentioned about the other 16 patients. It does, however, go on to say that perineal hernia was the commonest complication (26%).

With no further elucidation on this number should we assume that it was 26% of the 24 patients who developed a complication (six patients), or is it a percentage of the overall number - and is that number 56, or the total 40 that apparently completed the procedure? None of this is clear from the notes provided by the ACC (which I repeat, are no more than a transcription of the study abstract - indeed, one might suspect that this is the only part of the study that the medical advisor actually read). I had to read the full article to find the the actual number experiencing perineal hernia was 14.

Furthermore the study said that hernia occurred in nine (45%) of 20 patients who had laparoscopic ELAPE.

You might be wondering at this stage what I am debating. After all, ACC seem to have made their case, that with 45% of patients experiencing hernia from laparoscopic ELAPE, herniation must be considered an ‘ordinary consequence’ of the procedure - and I would be obliged to agree with them. Except…

Christine did not undergo laparoscopic surgery.

Since Christine’s surgery was not laparoscopic and she doesn’t fall within that number experiencing the higher rate of hernia she must indeed be represented by the remaining patients, 36 in number. So, 14 patients (overall), experienced perineal hernia as the complication, and since nine of them were in the group that had a different operation to Christine, we can further deduce that only 4 out of 36 in her category had a perineal hernia. That comes out as 11% which is a far cry from the 45% touted by ACC as a reason for decline on the basis of ‘ordinary consequence’.

The study statistical analysis was performed using IBM SPSS Statistics 20 for Mac. Fisher’s exact two-tailed test was used for statistical analysis, and a P-value <0.05 was taken as being statistically significant.

The study found the only conclusion that was statistically significant, with a P-value = 0.024 was in relation to laparoscopically assisted surgeries. All other data had P-values greater than 0.352 and therefore could not be considered statistically significant factors in the study.

We also need to remember that other confounders may have been present in the results of this study. It was done in one hospital district in East Yorkshire. For all we know, ALL of the operations may have been carried out by one surgeon. The poor results, for the laparoscopic ELAPE, could perhaps be associated with surgical incompetence for what is, essentially, a relatively new procedure.

For the 11% of patients, who had perineal hernia after the same operation as Christine, other factors could have contributed to the relatively higher, (as opposed to 3%), incidence.  Smoking or alcohol abuse may be high in that district, both of which have been associated with poor wound healing. We don’t know - the study didn’t control for those variables. Also, please note, the study, itself, excluded data from the non-laparoscopic arm, as being not statistically significant.

While I cannot say that there is very much statistical significance in any of the data presented by this study - what there is, only supports our case. Frankly I think it unprofessional, bordering on criminal, such a small study be used in this deceitful way, as an attempt to cast doubt on our claim that Christine’s injury was not an ordinary consequence of the surgery. The ACC case should be dismissed on this point alone.

Evidence that ACC were using the figure of 45% as a determining factor in the decision.

They have made the error of basing their decision on a small part of the study that isn’t relevant to this case. It was 45% of the 20 people undergoing a laparoscopic ELAPE that had hernia complications.

We are happy to acknowledge that laparoscopic ELAPE is more likely to result in perineal hernia complications, however it was not laparoscopic surgery that was attempted in this case and we would urge that the data for laparoscopic surgery not be confused with actual data that relates to Christine’s operation. (As seems to have been the case.)

We took the opportunity to write to Ian Daniels - a researcher who wrote a response to the Sayers et al article. He confirmed for us that while laparoscopic surgery is less invasive it is technically more difficult to fill the pelvic space.

Ian Daniels FRCS - Consultant Colorectal & General Surgeon, who has written a response to the Sayers et al article referenced by the ACC medical advisor, had the following to say regarding laparoscopic ELAPE, in a personal email to us:

“As laparoscopic surgery is minimally invasive from above, recovery is quicker, but it is technically more demanding to "fill the pelvic space" and therefore bowel (by gravity etc) will sit in the pelvic.”

The fact that more measures - such as use of mesh - were not put in place at the time of the surgery, and the possibility of perineal hernia was not brought up in discussion prior to the operation, indicate that there was no expectation of hernia, therefore, not an ‘ordinary consequence’ - even taking into consideration the risk factors associated with chemoradiotherapy. In fact most of the people undergoing this sort of surgery have also had chemoradiotherapy, certainly ALL the patients in the Sayers et al study had.

“As all patients had had pelvic irradiation, it was not possible to determine whether this is a risk factor.” (Sayers, Patel, & Hunter, 2015)

This would therefore lead to the conclusion that, even if it is a risk factor, the occurrence of perineal herniation is still only 1-3% (or perhaps as much as 11%, if the Sayers study could be considered significant), either way it is not an ‘ordinary consequence’. The tiny study, carried out in a hospital at Cottingham, East Yorkshire in the United Kingdom, deceitfully portrayed by the ACC medical advisor, does not stand up to the testimony by the surgeon, who has said:

 

“To the extent that Christine would not have developed a perineal hernia if she had not had rectal cancer surgery, then there is no doubt that the surgery was primarily responsible for this incident. It is not however an inevitable consequence of the operation, at least in the perineum. Parastomal herniation however is a different matter and as mentioned the rates of herniation around colostomies is very high.” (Vernon, 2015)

A perusal of the literature regarding the incidence of perineal hernia following abdominoperineal resection:

  1. (Fallis, Taylor, & Tiramularaju, 2013) “Perineal hernia is an uncommon but well-documented complication of abdominoperineal resection of the rectum. The reported incidence is between 0.34% and 7%”
  2. (Campos, 2005) “Perineal hernia (PH) is formed by the protrusion of intra-abdominal viscera through a defect in the pelvic floor. This is a rare complication after conventional abdominoperineal resection, pelvic exenteration, proctectomy, and other pelvic procedures. The purpose of the present paper is to report 4 cases of PH after laparoscopic abdominoperineal resection for rectal cancer and to review literature data about the incidence, predisposing factors, and treatment of this challenging problem. When added to other 3 cases previously reported in the Brazilian series of laparoscopic surgery, this group of 7 cases comprises a PH incidence of 3.5% after rectal resection procedures. Surgical treatment is indicated only in symptomatic patients with no signs of cancer recurrence. Proposed methods of surgical repair include abdominal, perineal, or combined approaches to the hernia in association with the use of autologous tissues or prosthetic meshes. Preventive measures are represented by closure of the pelvic peritoneum whenever possible, primary perineal suture and wound care to avoid infection.”
  3. (Aboian, Winter, Metcalf, & Wolff, 2006) “Of a total of 3,761 patients who underwent abdominoperineal resection (including non restorative proctocolectomy and pelvic exenteration) during the study period, 8 developed a perineal hernia (5 females).
  4. (Rayhanabad, Sassani, & Abbas, 2009) “Perineal hernia is a rare but known complication following major pelvic surgery. It may occur spontaneously or following abdominoperineal resection, sacrectomy, or pelvic exenteration. Very little is known about spontaneous perineal hernia. Surgical repair via open transabdominal and transperineal approaches has been previously described. We report laparoscopic repair of spontaneous and postoperative perineal hernia in 2 patients.”
  5. (Mjoli, Sloothaak, Buskens, Bemelman, & Tanis, 2012) “Abstract
    Aim  The purpose of this study was to determine treatment characteristics and clinical outcome for patients with perineal hernia after abdominoperineal excision (APE).
    Method  A systematic search of the literature revealed 40 individually documented patients, published between 1944 and 2010. Three additional patients treated at our centre were added. Patient characteristics, type of repair and outcome were entered into a database and a pooled analysis of these 43 patients was performed.”
  6. (He, Zhu, & Zhang, 2015) “Perineal hernias are uncommon complications following laparoscopic abdominoperineal operations. There is still very little known about perineal hernia. There are only few case reports to describe the repair of postoperative hernias after laparoscopic abdominoperineal resection (APR) in the literature. Here we present one patient with a perineal hernia after laparoscopic abdominoperineal resection for rectal cancer. The surgical management with manual purse-string suture is described and discussed in this case report.”

Besides noticing the words ‘uncommon’ and ‘rare’ as the major descriptors of the occurrence of perineal hernia following APR, we have a retrospective study involving 3,761 patients, from the Mayo Clinic database, that backs up the attending surgeon’s assertion that 1-3% of APR patients experience perineal hernia - as opposed to a cherry-picked study of 56 patients that may support the ACC assertion of ‘ordinary consequence’, if that study finding of 45% actually represented Christine’s operation, which it doesn’t. 


Having now ruled out the expected level of occurrence of perineal hernia as a major determining factor in ‘ordinary consequence’ - it remains to be seen whether the ‘other factors such as radiotherapy and chemotherapy’ can be considered major contributors or not.

Certainly the characterisation of these factors as ‘other factors’ by ACC would suggest that ACC themselves only regard them as supportive to their major premise, that ‘45% of hernia’ is the reason for considering ‘ordinary consequence’.

Even the Artioukh paper (Artioukh, Smith, & Gokul, 2007), referenced by ACC,  shows:

Bear in mind that this paper was a study of just 38 patients, only ten of whom showed impaired healing of the perineal wound. Also they were reporting on a variety of results of impaired healing - “dehiscence, chronic sepsis and/or persistent sinus” - not a perineal hernia among them.

A report from the Oncology Department of Waikato Hospital, dated 7 September, 2015, in respect of Christine, states that: “The irradiation did not include the perianal/perineal subcutaneous tissue and skin”, further undermining the assertion by ACC that radiation might be a factor contributing to the perineal hernia in this case.

“Our trial showed that bevacizumab plus XELOX allowed potentially curative resection in approximately 95% of patients and not a single patient experienced increased bleeding events or wound healing complications” (Gruenberger et al. 2008)

Delayed wound healing 7% 

PURPOSE: The aim of the study was to evaluate the efficacy and tolerance of pre-operative chemoradiotherapy with oral capecitabine in Greek patients with locally advanced, resectable rectal cancer.  CONCLUSION: Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer achieves significant rates of tumor downstaging and sphincter preservation with a favorable safety profile.) (Korkolis et al. 2007)

ACC notes in their conclusion of their review submission:

There is evidence in the limited study available of a relatively high risk of perineal hernia with the more aggressive procedure required in this case. And the need for pre/post-operative chemoradiotherapy would serve to further increase the risk – the overall risk such that development of an incisional hernia at the perineal defect may be regarded as not “out of the ordinary” under these circumstances.

This is a ‘non sequitur’ (an error of logic). In the Sayers et al study referred to by ACC, ALL the patients had preoperative chemoradiotherapy. Therefore, the final results INCLUDED the effects of preoperative chemoradiotherapy. They wouldn’t ‘further increase the risk’.

“As all patients in the present study had had pelvic irradiation, it was not possible to determine whether this is a risk factor.”

Indeed, most patients undergoing excision of a bowel cancer will have received preoperative radiotherapy, so the statistics regarding perineal herniation already include that as a factor, you cannot just add it on, hoping that it will make your case look better.

If, as (Artioukh, Smith, & Gokul, 2007) suggest, 17% of wound healing complications occur because of preoperative radiotherapy, and 9.8% because of preoperative chemotherapy, this means that those particular factors contributed to approximately 28% of the total of impaired healing in the 26% (10 out of 38 patients in their study), none of whom had perineal hernia complications.

So, at worst case scenario, of the 8 patients from the 3,761 in the (Aboian, Winter, Metcalf, & Wolff, 2006) study, who developed perineal hernia, perhaps 2 may have done so because of preoperative chemoradiation.

ACC notes in their submission:

25. In her review application Ms Sheehan noted “There was no discussion at

having a mesh implant as support during my 1st surgery in March 2014.”

26. ACC advised Ms Sheehan that this was a consent issue and she was

advised to lodge a new claim because ACC cannot consider cover for the

consent issue without receiving a specific claim for this as this issue was

not raised during the assessment of the claim for the perineal hernia nor

was it addressed.

They appear to have misconstrued the nature of the comment by Christine, which was in support of her (and the surgeon’s) expectation of a ‘normal’ outcome, nothing was discussed in terms of a need to support the excision by the use of a mesh implant. If the incidence of perineal hernia was an ‘ordinary consequence’ of the operation in terms of:

(i) the person’s underlying health condition at the time of the

treatment; and

(ii) the clinical knowledge at the time of the treatment.

then measures (like a mesh implant) would have been taken to make sure it didn’t happen. At the very least it would have been mentioned as a possible risk of the procedure. This discussion didn’t take place.

Conclusion

With the studies presented by myself, together with our own, more complete analysis of the articles presented by ACC, I have shown, on the balance of probabilities, that perineal hernia is a rare outcome - no more than 3%, (as stated by our surgeon), and is not an ordinary consequence of the the type of operation undergone by Christine. ACC have confused the facts of the study they presented, and made a decision based on evidence not in contention, and not relevant to this case.

In addition, ACC have tried to assert that pre and postoperative chemoradiotherapy have been a factor in delayed wound healing, but have not provided any studies to support this. Nor have they established that it was a factor in this case. We have shown that virtually ALL operations of this type are preceded by some form of chemoradiotherapy, yet the incidence of perineal hernia remains rare. The ‘balance of probabilities’ are against the respondent on this factor as well.  

They have suggested that ‘underlying health conditions’ may be a factor in this case and have tried to suggest that increased BMI may be one element of this. Apart from the tumour, there are no ‘underlying health conditions’. Christine is well within the ‘normal’ range for BMI measurement, and has been throughout the treatment. Yet another ‘balance of probabilities’ falling against the respondent.

I conclude that we have met the burden of proof required of us to show that the injury is not a necessary part, or ordinary consequence of the treatment, taking into account all the circumstances of the treatment, including-

(i) the person’s underlying health condition at the time of the treatment; and

(ii) the clinical knowledge at the time of the treatment.

 

 


Appendix 1

A

Treatment Injury Report - ACC’s decision - Moughan recommendation (“Treatment Injury Report.pdf,” n.d.)

B

From Treatment Injury Centre Medical Advice Response (“Treatment Injury Centre Medical Advice Response.pdf,” n.d.)

C

Treatment Injury Report - ACC’s decision - Moughan recommendation - Further response (subsequent to letter from van der Vyver)

Further notes by ACC after van der Vyver letter.JPG

Further notes by ACC after van der Vyver letter 2.JPG

Appendix 2

Section 32(1)


Appendix 3

Cover Decision - By Philippa Sim


Appendix 4

Risk factors for impaired healing of the perineal wound after abdominoperineal resection of rectum for carcinoma 

D. Y. Artioukh, R. A. Smith and K. Gokul


References

105-2008 McEnteer.pdf. (n.d.).

Aboian, E., Winter, D. C., Metcalf, D. R., & Wolff, B. G. (2006). Perineal hernia after proctectomy: prevalence, risks, and management. Diseases of the Colon and Rectum, 49(10), 1564–1568. http://doi.org/10.1007/s10350-006-0669-0

Artioukh, D. Y., Smith, R. A., & Gokul, K. (2007). Risk factors for impaired healing of the perineal wound after abdominoperineal resection of rectum for carcinoma. Colorectal Disease: The Official Journal of the Association of Coloproctology of Great Britain and Ireland, 9(4), 362–367. http://doi.org/10.1111/j.1463-1318.2006.01159.x

Campos, F. (2005). Silva e Sousa Jr. AH, Nahas CR, Lupinacci RM, Nahas SC, Kiss DR, Gama-Rodrigues J. Incidence and management of perineal hernia after laparoscopic proctectomy. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, 15, 366–370. Retrieved from http://scholar.google.com/scholar?cluster=4487144774464586324&hl=en&oi=scholarr

Fallis, S. A., Taylor, L. H., & Tiramularaju, R. M. R. (2013). Biological mesh repair of a strangulated perineal hernia following abdominoperineal resection. Journal of Surgical Case Reports, 2013(4). http://doi.org/10.1093/jscr/rjt023

He, Z., Zhu, G., & Zhang, S. (2015). Perineal Hernia after Laparoscopic Abdominoperineal Resection for Rectal Cancer: A Case Report and Review of the Literature. Journal of Cancer Therapy, 2015, 6, 222-226 Published Online  in SciRes. http://doi.org/10.4236/jct.2015.62024

Mjoli, M., Sloothaak, D. A. M., Buskens, C. J., Bemelman, W. A., & Tanis, P. J. (2012). Perineal hernia repair after abdominoperineal resection: a pooled analysis. Colorectal Disease: The Official Journal of the Association of Coloproctology of Great Britain and Ireland, 14(7), e400–6. http://doi.org/10.1111/j.1463-1318.2012.02970.x

Rayhanabad, J., Sassani, P., & Abbas, M. A. (2009). Laparoscopic repair of perineal hernia. JSLS: Journal of the Society of Laparoendoscopic Surgeons / Society of Laparoendoscopic Surgeons, 13(2), 237–241. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/19660225

Sayers, A. E., Patel, R. K., & Hunter, I. A. (2015). Perineal hernia formation following extralevator abdominoperineal excision. Colorectal Disease: The Official Journal of the Association of Coloproctology of Great Britain and Ireland, 17(4), 351–355. http://doi.org/10.1111/codi.12843

Treatment Injury Centre Medical Advice Response.pdf. (n.d.).

Treatment Injury Report.pdf. (n.d.).

Vernon, D. (2015, June 12). Vernon Letter to ACC 150612.pdf.


[1] No studies have been cited by ACC in support of these assertions