Consent
19. Mrs Y told us the surgeon did not tell them fistula was a potential risk of an Altemeier procedure. She says had they been told this was a risk, Mrs L would not have consented to the Altemeier procedure, as she was managing fine with the rectal prolapse.
20. We reviewed this issue with the help of our surgeon adviser and considered Mrs L’s medical records alongside the evidence Mrs Y provided.
21. Mrs L was reviewed in the colorectal surgical unit with Mrs Y in attendance on 31 January 2022 as she was experiencing a rectal prolapse. The operating surgeon noted her symptoms were variable as the prolapse would not always protrude to the same degree, if at all, when opening her bowels.
22. The operating surgeon noted Mrs L had Parkinson’s disease and worsening frailty. They also noted she struggled to mobilise and was losing weight. They thought the weight loss was likely due to Mrs L being afraid to eat because she did not want to open her bowels and risk the prolapse happening, and noted it was also probably due to increased frailty.
23. The operating surgeon explained the only way to treat the rectal prolapse was with an Altemeier procedure. They told Mrs L they were concerned about the risk of anastomotic leak and peritonitis (serious inflammation of the peritoneum which can be life-threatening – the peritoneum is a membrane that surrounds the abdominal organs).
24. The operating surgeon told Mrs L in their opinion, an anastomotic leak would be fatal for Mrs L, and there was a probable 10-20% chance this would occur. They also told Mrs L there could be a 50% risk of the prolapse recurring following the Altemeier procedure. The operating surgeon also made clear to Mrs L they would be happy to carry out the Altemeier procedure if she accepted and understood these significant risks.
25. The operating surgeon advised Mrs L to think about how badly the prolapse affected her quality of life and to what lengths she was willing to take a risk to try and resolve it, accepting it may well be a temporary resolution. They gave Mrs L time to discuss her options with her family and arranged a follow-up call for a later date.
26. Mrs L had a telephone consultation with the operating surgeon on 6 May 2022. Mrs L reported the rectal prolapse was gradually getting worse and was coming out more frequently. The operating surgeon noted Mrs L had been given plenty of time to digest the information and was aware of the risks. They noted they were happy Mrs L was ‘fully versed’ regarding the procedure and Mrs L had requested to be listed for the Altemeier procedure later that year.
27. Mrs L had the Altemeier procedure on 14 November 2022. Mrs L signed a consent form on the day of the procedure. The consent form lists recurrence, bleeding, infection, anastomotic leak, incontinence, deep vein thrombosis (a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a serious condition that occurs when a blood clot blocks blood flow to part of the lung).
28. Sadly, Mrs L developed an anastomotic leak following the surgery, and this led to the development of a rectovaginal fistula.
29. Mrs L also unfortunately contracted C-Difficile and this made the effects of the fistula worse. Our surgeon adviser told us fistulas are often small in size and a patient with a healthy bowel function may only notice small spotting of liquid coming from the fistula.
30. In Mrs L’s case, she was experiencing increased bowel symptoms due to the C.Difficile, and this meant she had much more diarrhoea coming through the fistula. We do not underestimate how distressing this will have been.
Our view
31. The medical article ‘Adult Rectal Prolapse and Altemeier’s recto-sigmoidoscopy: current status and the place of perineal repairs’ explains rectovaginal fistula is a rare complication of Altemeier procedure.
32. Consent guidance from the GMC states, ‘patients have the right to be given the information they need to make a decision and the time and support they need to understand it…medical professionals must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options.’
33. We have seen evidence Mrs L was informed about the serious risk of anastomotic leak and 10–20% chance of potential death, and she was appropriately given time to think about her options.
34. We consider these actions were in line with the GMC guidance ‘The seven principles of decision making and consent’. These say ‘it would not be reasonable to share every possible risk of harm, potential complication or side effect. Instead, you should tailor the discussion to each individual patient, guided by what matters to them, and share information in a way they can understand.’ We therefore do not see failings in this rare complication not being explained during the consent process.
35. We saw evidence the Trust took time to understand Mrs L’s condition and what she would like to happen. It also advised her about the most serious risk of anastomotic leak, which was felt to be the most likely risk to occur in Mrs L’s case.
36. We appreciate with hindsight, Mrs Y believes Mrs L would never have gone ahead with the procedure had she known what a fistula would entail. We recognise how distressing the effects of the fistula combined with the C-Difficile infection were for both Mrs L and Mrs Y.
37. Sadly, it would not have been known that Mrs L would contract C-Difficile after the procedure. Therefore, even if she had been told about the rare complication of a fistula, the information she would have been given about this would not have reflected her personal experience of having C-Difficile at the same time.
38. We did, however, see evidence the rectal prolapse had become so bad Mrs L was willing to consent to the Altemeier procedure despite being aware an anastomotic leak may occur and could lead to a one in five chance of death. We consider Mrs L had the opportunity to make an informed decision about going ahead with surgery to address her self-reported worsening rectal prolapse.
39. On the balance of probabilities, we consider it is likely Mrs L would likely have still consented to the procedure had she known about the rare possibility of a fistula, as she had consented to the more likely risk of a one in five risk of death.
40. We have therefore seen no failing in the consenting process and will take no further action on this part of Mrs Y’s complaint.
Follow-up
41. Mrs L says it took months to get a follow up appointment after the Altemeier procedure. She says her mother was suffering during this time due to the development of a fistula and she was experiencing diarrhoea coming from her rectum and vagina. She says it was distressing as she did not know when her mother was going to get an appointment and she did not know if what was happening was serious or causing further damage.
42. We reviewed this issue with the help of our surgeon adviser and physician adviser using Mrs L’s medical records and the evidence Mrs Y has provided.
43. The GMC guidance ‘Good medical practice’ says ‘doctors must promptly provide or arrange suitable advice, investigation or treatment where necessary when providing clinical care.’ It also says, ‘clinicians must treat patients with kindness, courtesy and respect. They should be alert to signs of pain or distress and take steps to alleviate it.’
44. The plan following Mrs L’s Altemeier procedure was for a routine follow up appointment in three to four months’ time.
45. Mrs L’s GP tested her for C.Difficile on 9 December 2022. They referred Mrs L to the surgical assessment unit (SAU) on 12 December 2022 as Mrs L was passing loose stool from her vagina.
46. A senior registrar in the SAU queried whether Mrs L’s symptoms could be due to a fistula and planned to discuss Mrs L with the operating surgeon the following day.
47. The senior registrar made the operating surgeon aware of Mrs L’s complications on 13 December 2022. Mrs L’s GP also wrote an ‘urgent expediate letter’ to the operating surgeon on 15 December 2022 to ask that her appointment be brought forward. In this letter, the GP explained Mrs L had had not passed normal stools since the surgery and had only passed peri-vaginal stool. They also advised Mrs L had C.Difficile, which added to this situation.
48. The operating surgeon responded to the GP’s referral and noted Mrs L had been assessed on the SAU. They noted they would see Mrs L at the follow up appointment in January 2023. No further action was noted at this time.
49. On 22 December 2022, Mrs Y had a telephone appointment with a consultant physician in the department of elderly medicine in relation to the fistula and distressing symptoms her mother was experiencing. The clinic letter from this appointment was sent to Mrs L’s GP. The consultant physician noted Mrs L’s difficult situation and that ‘things have unfortunately gotten out of hand with the development of C.Difficile infection and now she is significantly faecal incontinent.’
50. The consultant physician also noted Mrs Y’s distress and that she felt her mother’s Parkinson’s was ‘terrible’. The consultant physician noted they were not in a position to alter Mrs L’s management at present and suggested they and the GP work together to help with the faecal incontinence, ahead of Mrs L’s surgical follow up consultation in January 2023. They also noted they would contact Mrs L again in one month.
51. Mrs L saw the operating surgeon on 17 January 2023. They noted Mrs L’s vaginal diarrhoea had resolved after three to four weeks and had gradually settled down with antibiotic treatment. After this time, Mrs L had contracted various chest infections and had needed antibiotics for these. Mrs L was noted to be using a ‘couple of pads a day’ for her vaginal incontinence and had been passing some stool rectally.
52. The operating surgeon examined Mrs L and noted a likely small fistula at the apex of the vagina. They arranged a CT scan to consider this further, and the hope was that this would settle down gradually, as Mrs L was likely too frail for further surgery.
53. The consultant physician also contacted Mrs Y after this consultation, on 26 January 2023 and noted there was a plan in place for a CT scan and that Mrs L was under the care of the operating surgeon.
54. Mrs L’s CT scan took place on 3 February 2023. This was noted to be difficult to interpret, but it was felt there may be a small connection between the rectum and vagina. These results were discussed in the next consultation on 24 March 2023 and the operating surgeon completed a further examination and felt there was likely a very small connection.
55. The operating surgeon gave advice around managing Mrs L’s symptoms and starting the use of stimulant suppositories to help the bowel movements.
56. Mrs L had an appointment booked with the consultant physician for 30 March 2023.
Our view
57. We have considered if the operating surgeon should have done more when they became aware Mrs L was experiencing complications. Our surgeon adviser told us the management of a rectovaginal fistula depends on many factors including the severity of the symptoms, the exact location of the fistula, and the underlying cause.
58. As an early complication after the Altemeier procedure there are two options for treatment of this:
• Conservative treatment which includes seeing and assessing the patient, reassuring them wait to see if the symptoms spontaneously improve, treat the C. difficile infection (in this patients case) allow time for the swelling to subside post the surgery and then consider an elective repair many months later if the patient is fit enough for surgery and the ongoing symptoms warrant an operation.
• An alternative strategy would be to suggest a colostomy. This is an operation where the colon is brought up to the skin on the abdominal wall and sutured to the skin. The faeces then collect into a stoma/colostomy bag. This prevents any faeces travelling further down the colon to the site of the fistula. The advantage of this would be the patient would no longer have faeces coming into her vagina. Many patients have a complete aversion to having a stoma bag and this is understandable, and they may prefer to continue with the symptoms related to the rectovaginal fistula.
59. We cannot see either of these options were explored after Mrs L’s visit to the SAU on 12 December 2022. We can see the senior registrar made the operating surgeon aware of Mrs L’s complication and concerns. Two days later, Mrs L’s GP also asked for her follow up appointment to be brought forward. We can see the operating surgeon noted Mrs L’s assessment in the SAU and responded to say they would see her in the scheduled follow up in January 2023.
60. We consider this appointment should have been brought forward and Mrs L’s concerns (also highlighted by the GP) should have prompted this. Our surgeon adviser notes an urgent appointment would have helped Mrs Y and Mrs L and reduce the stress and anxiety they would naturally have after experienced after this complication developed. This action would also have been in line with the GMC’s ‘Good Medical Practice’, which says ‘clinicians must treat patients with kindness, courtesy and respect. They should be alert to signs of pain or distress and take steps to alleviate it.’
61. While there is no official guidance on when an urgent appointment should be made, it would be reasonable for the surgeon to make space so they could review Mrs L urgently in clinic. Our surgeon adviser suggests two weeks would be a reasonable time frame, in line with their clinical experience.
62. We therefore consider the lack of an earlier appointment was a failing.
63. We next asked our physician adviser if the consultant in elderly medicine should have done more after the telephone consultation on 22 December 2022. Our physician adviser told us Mrs L was experiencing several medical issues at this time, which included:
• C.Difficile, which was being treated with antibiotics by the GP • faecal incontinence, which was being exacerbated by the C.Difficile infection and also awaiting investigation by the surgical team • Parkinson’s disease.
64. We recognise Mrs L’s C.Difficile infection was being managed by her GP and investigations for faecal incontinence had been requested by the surgical team. However, we consider further action should have been taken in relation to Mrs L’s distress and the concerns about her Parkinson’s disease, as these were not being addressed at this time.
65. We consider an earlier face to face appointment would have provided reassurance to Mrs Y and Mrs L. It would also have been an opportunity to explore what additional help Mrs L required and whether her medication for Parkinson’s disease needed to be adjusted. Our physician adviser said it is possible the medication could not be adjusted due to other issues such as blood pressure but says this could not be adequately assessed in a telephone consultation.
66. We consider these actions would have been appropriate in line with the GMC’s ‘Good Medical Practice’ as this says clinicians must adequately assess the patient’s conditions and promptly provide or arrange suitable advice, investigations or treatment where necessary.
67. We therefore also consider this was a failing.
Impact of failings identified
68. Mrs Y told us it was distressing having to constantly push for a follow-up appointment. She said they were worried and distressed as they did not know if what was happening to Mrs L during this time was serious or could be causing further damage.
69. The Trust was aware Mrs L was experiencing a distressing complication post-procedure and did not attempt to bring her appointments forward to provide reassurance sooner.
70. Our surgeon adviser told us the complication would not have become worse due to any delay in seeing Mrs L. We therefore do not see this delay had a clinical impact. Our advisers agreed the impact of this matter is unnecessary anxiety and distress to both Mrs L and Mrs Y. We therefore consider there was an emotional impact as a result of the failings.
71. We recognise Mrs L had a telephone consultation with a consultant physician on 22 December 2022, but the physician was unable to offer help in relation to the fistula and did not attempt to see her in person to provide reassurance any sooner than a planned appointment on 30 March 2023.
72. We consider the length of time Mrs L and Mrs Y experienced unnecessary distress and anxiety was from 12 December 2023, when she was assessed in the SAU until she was seen in person by the operating surgeon on 17 January 2024.
73. We consider this to be a failing. We have not seen the Trust has recognised this failing and its impact. We have therefore made recommendations to address this.