Not being told that a routine colonoscopy could mean major surgery
19. Mr D says when he went to the hospital for an optical colonoscopy on 16 April 2019, he signed a consent form and he accepted the risks associated with this procedure. These risks included a chance of one in 2,000 of the bowel being perforated (although, in the Trust’s pre operative letter dated 3 April 2019, the consultant gives the chance as one in 1,000). Mr D says although the Trust explained the risk of perforation, it did not explain what this might mean for him as an individual. He says the outcomes of attending a routine outpatient colonoscopy should not involve put your life at risk and being permanently disfigured or disabled. He says he was not told about the risk of needing possible major life-saving surgery.
20. Mr D says the colonoscopy procedure on 16 April 2019 appeared to have gone well, but a single 5cm polyp was found. He says the doctor doing the colonoscopy called the consultant on duty that day to ask for advice. He says the consultant said although it was a slightly large polyp, in his view, it was safe to remove it immediately. Mr D was later discharged and went home. Unfortunately, that evening, Mr D experienced acute pain. His wife called for an ambulance, which soon arrived, but it did not take Mr D to hospital. The paramedic alerted the out-of-hours GP and Mr D saw his own GP the next day. His GP called the Trust’s surgical team and they agreed Mr D should come in straightaway for likely emergency surgery. Mr D says, on arrival at the hospital, he was admitted quickly and had further surgery. He then spent two days in intensive care and was sent home on 29 April. He was left with a stoma, a large surgical wound and an incisional central hernia. He says the stoma was successfully reversed in July 2021, but it looks increasingly likely that the hernia will not be repaired.
21. The Trust’s letter to Mr D dated 3 January 2020 says the colonoscopy procedure was performed by two experienced consultants and perforation is a recognised complication of the procedure. It says there was no indication of perforation at the time of the polypectomy, the polyp needed to be removed and a colonoscopy was the best method of removal.
22. We can see from the medical records the relevant consent form was signed by Mr D on 16 April 2019. The consent form itself does not specifically list any of the complications associated with a colonoscopy, but it does refer to an accompanying patient information leaflet. This leaflet lists the risk of perforation as being one in 2,000. It adds, ‘If this were to happen, we would admit you to hospital immediately and, in some cases, it would need to be treated with an emergency operation. A possible outcome of this surgery could be a colostomy [a surgical procedure to divert one end of the colon through an opening in the stomach].’ So, Mr D was informed surgery was a potential outcome of a perforation.
23. The GMC’s ‘Ethical Guidance for Doctors: Decision Making and Consent’ says, ‘You must give patients the information they want or need to make a decision. This will usually include (a) diagnosis and prognosis, (b) uncertainties about the diagnosis or prognosis, including options for further investigations, (c) options for treating or managing the condition, including the option to take no action, (d) the nature of each option, what would be involved, and the desired outcome and (e) the potential benefits, risks of harm, uncertainties about and likelihood of success for each option, including the option to take no action’.
24. This guidance also says, under ‘Finding out what matters to a patient’, ‘you should usually include the following when discussing benefits and harms: (a) recognised risks of harm that you believe anyone in the patient’s position would want to know. You'll know these already from your professional knowledge and experience, (b) the effect of the patient's individual clinical circumstances on the possibility probability of a benefit of harm occurring, (c) risks of harm and potential benefits that the patient would consider significant for any reason and (d) any risk of serious harm, however unlikely it is to occur’. Our clinical adviser says the Trust’s consent procedure appears to meet the standards for obtaining consent and the consent form uses the standard NHS format for obtaining informed consent.
25. Based on the evidence we have seen, including what Mr D and our adviser have told us and which is supported by the relevant clinical records, we are satisfied Mr D was given the information he needed to fully consent to the risk of his bowel being perforated as a result of the colonoscopy. This information included the specific risk of possibly needing to have an emergency operation. We do not find any failings on the part of the Trust in terms of this part of the complaint.
Not being told about the increased risk of perforation in the event of a polypectomy
26. Mr D says although he signed the consent form for the colonoscopy and staff explained there is a one in 2,000 chance of perforation, he was not told the chance of perforation is much higher when a polypectomy is performed. He says this was not explained during the colonoscopy, during which he was sedated. He says if events during a procedure mean the risk of a bad outcome significantly increases, this should be made very clear to the patient. He feels he should have been given time to consider the increased risk of bowel perforation before consenting to the polypectomy. He says even though it is likely he would have gone ahead with the procedure, he would have had time to think it over and discuss the risk with his family.
27. The Trust’s letter to Mr D dated 5 February 2020 says the consultant who carried out Mr D’s polypectomy had taken advice from the consultant on duty at the time. It says he did this because Mr D’s polyp was approximately 5cm and the colonoscopist (colonoscopy specialist) on duty had extensive experience and expertise in doing large polypectomies. The duty colonoscopist explained that polyps over 3cm are rare and potentially more difficult to remove but, in this case, it was safe to remove it. In response to Mr D’s comments about the need for clearer literature on endoscopies for patients in future, the letter says all patients are now provided with an information leaflet when they are referred for an endoscopy (all investigations using a camera to look inside the body). It says this leaflet has recently been updated.
28. We can see the leaflet given to Mr D ahead of his colonoscopy on 16 April 2019 explains how this is the only test that allows endoscopists (endoscope specialists) to view the inside of the lining of the bowel and, if necessary, do a biopsy (a medical procedure to remove a piece of tissue for analysis). It also says it is the only test during which it is possible to remove polyps, should any be found. If not removed, some types of polyps may grow and eventually lead to cancer. The leaflet says removing a polyp is a good way of reducing the risk of bowel cancer, but it does not explain the polypectomy increases the risk of bowel perforation.
29. Our adviser says the issue of whether Mr D should have been given time to consider the risks of having the polyp removed the same day is a matter of clinical judgment. They say considerations include the need to carry out a polypectomy at the earliest opportunity as leaving a polyp carries the risk of it becoming cancerous. So, the Trust’s argument the endoscopist felt it appropriate to remove the polyp during the index (original) colonoscopy is reasonable.
30. Our adviser also notes that carrying out the procedure later would not reduce the risk of perforation. That is, the risk of perforation is the same whether the procedure is carried out at the index colonoscopy or whether the patient is brought back for a second procedure. Although Mr D was told the risk of perforation was one in 2,000 during a standard colonoscopy, he was not told the risk of perforation increases to one in 500 following a polypectomy. Mr D does not appear to have been told of the increased risk of perforation following a polypectomy, which he should have been.
31. Our adviser says the perforation rate for larger polyps can be even greater than the one in 500 risk given in British Society of Gastroenterology standards. Our adviser also says if the endoscopist feels the patient needs to give consent again in light of finding a large polyp during the index colonoscopy, the procedure should be rescheduled. This is in line with the GMC’s Ethical Guidance for Doctors: Decision making and Consent, which under ‘Supporting patients’ decision making’, says to help patients understand and remember relevant information, a doctor should give them time and opportunity to consider it before and after making a decision.
32. But, our adviser says, by delaying, the issue of inconvenience for the patient also needs to be taken into account. Our adviser says a second procedure would require the patient to take more time off work and to go through preparation for a bowel procedure for a second time. In this case, the endoscopist made a clinical decision to remove the polyp at the index colonoscopy. Although some endoscopists may have chosen not to remove the polyp at that time and would have brought the patient back for a second procedure, this is a matter of clinical judgement. The patient information leaflet should be amended to include the increased risk associated with a polypectomy.
33. We cannot be sure of Mr D’s decision had he known about the increased risk of perforation related to a polypectomy. But this was a missed opportunity to allow him to weigh up the increased risk of perforation against the increased risk of unidentified cancer, should he have chosen to delay or decline the procedure. We recognise Mr D’s follow-up surgery greatly affected him in terms of direct financial loss through time off work and through the distress of further surgery and its clinical outcome. We accept this financial impact would have been the same for Mr D whether he had undergone the polypectomy on 16 April 2019 or later, after thinking it through. In our view, this loss of opportunity to make a considered decision was an injustice for Mr D. We make recommendations below for how the Trust should put right the impact of this failing.