“For the purposes of the claim against the Trust, the Trust admits that the Claimant had not been appraised of all material risks prior to undergoing transanal total mesorectal excision (taTME) on8 December 2015 . The risks of anterior resection syndrome, urinary and sexual dysfunction were not discussed and this constitutes a breach of duty.”
“Ensuring that patients are made aware of the ‘new’ status of the procedure they are to undergo; Preparing appropriate patient information leaflets for the new treatment/procedure”
“1.2.4 Introduction of new techniques Introduction of new clinical interventions and surgical techniques (including equipment) that deviate significantly from established practice and are not part of an NHS local ethics committee research programme must be underpinned by rigorous clinical governance processes, having the patient’s interests as the paramount consideration. If you are introducing new surgical techniques and technologies you should: - Discuss the technique with colleagues who have relevant specialist experience and seek formal approval from your medical director. - Follow local protocols with regard to obtaining approval by the local ethics committee or the local clinical governance committee. These should include the provision of evidence that the new technique is safe and that all clinical staff who plan to use the new technique will undertake relevant training, mentorship and assessment.”
“I don't think NICE was making any comments about this sort of granular detail of the level of training and mentoring and supervision and so on. They were not making these recommendations. They're not in the NICE document.”
“Dr Ellis: So the system was that you would supervise each other effectively yes? Mr Courtney: We went on the training course together, yes, and we both completed the training, yes.”
“Mr Feeny: Mr Jenkins, you're a very experienced surgeon and sometimes in the courts we can forget about what happens in clinics and operating theatres and places like that but there is a whole team ready to go, isn't there, at that time. Everyone is geared up to start that surgery, aren't they? Mr Jenkins: That's -- that's not an acceptable reason to put somebody through an operation. Mr Feeny: I'm not suggesting it is. I'm just trying to explain. Mr Jenkins: And it would not be the first time that I have cancelled major extensive surgery because I do not feel the patient is ready or has fully comprehended what is about to happen to them. Mr Feeny: On the day -- Mr Jenkins: At the hospital I would rather take the cost of losing a day of operating than either have my conscience or some aspect trouble me that I made the wrong decision in that regard.”
“…I: 10mm umb[ilical] port, 12mm RIF [right iliac fossa] 5mm epigastric and left ports. P: medial to lateral dissection, IMV [inferior mesenteric vein] and IMA [inferior mesenteric artery] taken with hemolock clips. Splenic flexure fully mobilised. Lateral dissection continued to pelvic brim. 1 nylon purse string inserted some faecal leakage, washed out ++. Transanal gel path port inserted, TATME dissection performed with diathermy to join abdominal dissection. Tethering at 5 o’clock and difficult dissection. Some lap abdominal assistance. Specimen delivered through Alexis [wound retractor/protector] in extended midline port incision, sigmoid descending junction divided and colon delivered to anal canal. Hand sewn colo-anal anastomosis with 30 Maxon interrupted tension free good blood supply. Defunctioning ileostomy in RIF. PDS loop 1 to fascia, clips to skin. 14G drain to pelvis… .”
“Dr Ellis: Bearing in mind the special conditions imposed by NICE on college governance consent record keeping, it’s surprising, isn’t it, that an operation lasting nearly nine hours has been reduced to so few lines. It reads rather like an uncomplicated laparoscopic appendicectomy? Mr Courtney: Yes. Dr Ellis: It’s not adequate for governance purposes or research and investigation, is it? Mr Courtney: Well, it’s not a long enough operation note, yes, I agree. Judge Roberts: Sorry, it’s not. Mr Courtney: It’s not a long enough operation note, I agree. … Dr Ellis: So it’s accepted it’s not detailed enough. Mr Courtney: Yes. Dr Ellis: For number 2? Mr Courtney: Yes. Dr Ellis: When special conditions are imposed, but it’s startling, isn’t it, bearing in mind what we know about potential risks including pelvic nerve injury, there is no record, is there, that any of the relevant nerves were ever identified or preserved? Mr Courtney: There’s no record of it, no. Dr Ellis: No. And what probably happened, didn’t it, is that during the part described as a difficult dissection, this is where those pelvic nerves, which presumably hadn't been identified and preserved, were injured? Mr Courtney: I presume so, yes.”
“In the circumstances, it is, on the Defendants’ case, overwhelmingly likely that even with fuller information the Claimant would have accepted Mr Courtney’s advice to undergo a TaTME in particular, because of the risk of colostomy from any other procedure.”
“Dr Ellis: When you say in your statement ‘I didn’t have access to the imaging’, that’s not true, is it? You had access to the reports and that’s why they’re in the letter? Mr Courtney: Well, I had access to the CT. The MRI is often not reported until the time of the MDT... Dr Ellis: I understand. So you accept that your statement is incorrect? Mr Courtney: Yes. It would read incorrect, yes … Dr Ellis: So your statement is factually wrong in that regard? Mr Courtney: Yes, well I think this was made seven years later. Dr Ellis. Quite. And memory fades? Mr Courtney: Yes. So I think, you know, I see 30 to 40 patients in clinic a week, so I think remembering a consultation seven years ago is difficult…”
“Mr Feeny: … The first is this: that you at all times have been very keen to avoid a colostomy, haven’t you, a permanent colostomy? Mr Snow: No. At that time, I wasn’t. At that time it wasn’t really discussed, because I was going to have a temporary colostomy. ... I read that in his statement and I’m just saying no, that did not happen.”
“He does have an appointment with me next week at the RUH, but because of increasing anxiety he decided to come and see me sooner.”
“Dr Jenkins: It doesn’t necessarily mean that the surgery has to be done within 31 days. In the real world interpretation of that. … It doesn’t reflect any oncological urgency. It’s a metric to ensure the patients are processed in a suitable timeframe. … The first aspect is if a patient chooses to defer treatment, that is entirely their choice and even if it might yield what is called a breach then the trust must accept that. They cannot coerce a patient into treatment, be that earlier or otherwise. That’s the first thing. The second thing is when it comes to short course radiotherapy, there has been a historical concern regarding morbidity and if it is delayed beyond a week, although the timeframes are very broad across the NHS, then that may induce a worsening of outcome. There are data from NHS England that look at time to surgery from short course radiotherapy and actually find little detriment to clinical outcome, post-surgical outcome by waiting a couple of weeks, up to three weeks, four weeks.”
“…The task of the Court is to see beyond stylistic blemishes and to concentrate upon the pith and substance of the expert opinion and to then evaluate its content against the evidence as a whole and thereby to assess its logic. If on analysis of the report as a whole the opinion conveyed is from a person of real experience, exhibiting competence and respectability, and it is consistent with the surrounding evidence, and of course internally logical, this is an opinion to which a judge should attach considerable weight.”
“I think it would be difficult to prove a difference in terms of quality of life”
“Yes, so once again I admit that none of the article copies were sent to me. … I was always under the impression that each side discloses literature to the other side.”
“Dr Ellis: I'm sorry, you're not answering the question again. Mr Meleagros: -- with the exception of urethral injury. Dr Ellis: You're not answering the question again.”
“Dr Ellis: No. Now, pedunculated means on a stalk. Yes? Mr Meleagros: It could mean that but the stalk could be broad. Dr Ellis: I'm sorry, the dictionary definition of a peduncle, as we all know, is a stalk. This hasn't got a peduncle, a stalk? Mr Meleagros: You're right, it hasn't. Wrong use of the word.”
“The other thing that I’m not clear when it comes to our radiology colleagues’ reporting is whether the distance is measured in the sagittal plane, the side view, where they draw these two lines in the anal canal and then another line at an angle in the rectum, or whether the distance is measured as a single perpendicular line from where they think the anal verge is to the tumour. And that distance would clearly be shorter because it is the hypotenuse of a right angle triangle. … So all in all I’m not trying to make a case that I disagree with any definitions of low, middle or rectal; I’m just saying that the whole thing is a lot more nuanced than that and as practising surgeons, we’re more interested as to whether we have sufficient tissue below the lower border of the cancer to allow us to perform a so-called sphincter saving resection and that’s why inadvertently I use the term low, not necessarily to apply to the definition of low rectum but to apply the definition that in the eyes of a practising colorectal surgeon such as myself, this cancer is low. … Dr Ellis: But all these qualifications about which measuring points were used, whether you can see the skin around the anal canal entrance or not, where the height of the tumour is, is it from a sagittal line or a perpendicular, from a hypotenuse, et cetera et cetera. This wasn’t something that suddenly dawned on you when you came to court yesterday and read the report about pelvimetry, was it? Mr Meleagros: Actually it was, unfortunately. I realised when I was speaking to Dr Scullion outside court yesterday morning when he arrived. Dr Ellis: So did you tell him about your concerns? Mr Meleagros: Yes. Dr Ellis: The inaccuracy of the measurements? Mr Meleagros: Yes, I did in our conversation but as you rightly point out I am not a radiologist.”
“Dr Ellis: On a balance of probabilities, I know you prefer to avoid that, it was highly unlikely that an experienced laparoscopic surgeon doing it their usual way from the top down, highly unlikely that this would have been converted to an APER and colostomy, isn't it? It's less than 50 per cent risk? Mr Meleagros: It’s less than 50 per cent, yes, …”
“Dr Ellis: There’s no evidence before the court as to either what the range of a normal male pelvis is or what the dimensions were in this case? Mr Courtney: No.”
“5. What is the diameter of pelvic outlet? DS and DB: We have agreed it is 91mm on MRI and 92mm on CT. 6. What threshold is used to define a narrow male pelvic outlet? DS and DB: We have agreed the threshold is 82.7mm as per article available in latest trial bundle.”
“Dr Ellis: … it’s startling, isn’t it, bearing in mind what we know about potential risks including pelvic nerve injury, there is no record, is there, that any of the relevant nerves were ever identified or preserved? Mr Courtney: There’s no record of it, no. Dr Ellis: No. And what probably happened, didn’t it, is that during the part described as a difficult dissection, this is where those pelvic nerves, which presumably hadn’t been identified and preserved, were injured? Mr Courtney: I presume so, yes.”
“Mr Feeny: But if you’ve got to the section, to the point you want, you don’t go looking for nerves, do you? Mr Jenkins: No, it’s part of the anatomical steps in a mesorectal dissection.”
“I think there is an imperative. Part of the anatomical dissection of the mesorectum requires identification of the superior hypogastrics to permit entry into a safe mesorectal plane. … It’s a fundamental step in the procedure.”
“There are a multitude of mechanisms for nerve injury inter-operatively. There can be stretching that might produce a neuropraxia, a bruising of the nerve which results. There can be thermal injury which may produce a permanent injury to the nerve but in my opinion often produces a more transient disturbance given that the nerve fibres that are still intact, you can regenerate. … In my opinion it will produce a transient. It is the division or resection that produces permanent loss of function.”
“Dr Ellis: And that’s the whole point about nerve identifying and preserving surgery going back to the 1980s when Professor Heald seems to have kicked it off long before the Japanese. The very point is if you make an effort, as Mr Jenkins said, if you go and look for them you will find them and we have photographs demonstrating that. Mr Meleagros: Yes. … Mr Meleagros: I accept that Professor Heald, the pioneer of TME went and learned the anatomy and saw the anatomy and said this is possible. Of course it’s possible. It’s perfectly possible, the nerves are there so if you look for them carefully you will find them. Dr Ellis: Exactly. Mr Meleagros: But the point is in surgical practice this does not happen. … Dr Ellis: I mean, that’s not correct, is it? Because these studies going back to the 1980s refer very clearly with careful dissection to the nerves being visible, don’t they? Mr Meleagros: Yes, so these fascial layers are very flimsy, so you can very easily enter them and see the nerves. … In Western patients we just don't see them very often or very rarely as I described to your Lordship. And we don't deliberately look for them.”
“Dr Ellis: … That’s what Mr Jenkins described yesterday, didn’t he? He talked about inexperienced surgeons either consciously or unconsciously straying outside the correct plane. It’s recognised that this happens during the learning curve, isn’t it? Even if you’re experienced from top down. Mr Meleagros: It is recognised, yes.”
“Mr Feeny: It’s not disputed the nerves must have been injured during the course of surgery. The question is whether that denotes wrong surgical technique. Yes? That it can only happen through wrong surgical technique? Mr Jenkins: If the correct anatomical plane, which is the mesorectal fascia, is followed … then it would be reasonable to say that it is unlikely to produce significant nerve injury. Indeed there were reports where autonomic nerve preservation has been performed, the incidences of urinary and sexual dysfunction are relatively low. … Mr Feeny: So the question then is a factual one: did they get into the wrong plane? Mr Jenkins: Yes, based on the outcome and based on the scant intraoperative operation note detail. … I described it as a full house earlier, but in order to achieve the multitude of different injuries we saw on Mr Snow, by definition, in my opinion … one would have to go into the wrong planes on a multitude of positions within the pelvis. … In a multitude of positions during mesorectal dissection. And I would propose, based on my own experience and my understanding of proficiency gain literature, that that is far more likely to occur on your second patient.”
“The formal histopathology specimen report does not clarify whether the specimen had followed the suitable mesorectal fascial plane dissection as would be reflected in many modern rectal cancer histopathology minimum data set reporting templates.”
“Dr Ellis: My point was simply this: you couldn’t achieve all of Mr Snow’s erectile, ejaculatory, orgasm, bladder dysfunctions by a simple injury at 5 o’clock, could you? I think you accept that. Even the 2 to 3 centimetre plexus where some fibres merge is not at 5 o’clock? Professor Sethia: I accept that. Dr Ellis: And in fact you couldn’t achieve the full spectrum of Mr Snow’s injuries, could you, with unilateral nerve injury in this case; it is unlikely, isn’t it? Professor Sethia: I think it is unlikely. Dr Ellis: And it follows, therefore, that it is more likely than not that Mr Snow has suffered multiple nerve injuries at different sites? Professor Sethia: I think he’s -- my opinion is he’s probably suffered a bilateral nerve injury.”
“Dr Ellis: But it’s self-evident, isn’t it, if you’re sexually active you’re having sex. We don’t know how often or with what degree of satisfaction but you can’t be sexually active without an erection, can you? Professor Sethia: Yes, you can. You can be sexually active because you can, for example, stimulate your partner and that would count as sexual activity, without you necessarily personally achieving sexual satisfaction.”
“Mr Meleagros: That’s why I said severe and incidentally you said urinary, but I think in this paragraph I just talk about sexual. Dr Ellis: Well, no, you didn't, because if you look at the top of page 336 that's why I asked you. On a balance of probabilities he was expected to suffer with urinary and sexual dysfunction? Mr Meleagros: Yes, you are right, sorry, sorry. So I think urinary was stretching it a bit. Judge Roberts: So that's stretching it a bit? Mr Meleagros: I think I was referring to sexual when -- because these figures are sexual dysfunction, not urinary. Dr Ellis: So on a balance of probabilities he was not condemned inevitably to bladder dysfunction, was he? That's what you have just said. Mr Meleagros: Yes, I agree there. Because the subsequent data does not support this statement. So I went beyond what the papers that I was aware of said, these are primarily on sexual.”
“Mr Feeny: Your position is that if there had been a bigger rectal remnant it would have been better [the LARS]? Mr Jenkins: That is part of it, but the other component which is not necessarily addressed under the banner of LARS is his continence and there is a separate issue with his sphincter, which is not necessarily related to LARS, which confounds the LARS, potentially, and in my opinion makes his LARS worse … .”