Brought forward operation 18. Mr A says the Trust brought Ms B’s non-emergency operation forward by a week (from 20 June to 13 June 2022) because of a cancellation, which contradicted the original operation plan.
19. The GMC guidance outlines clinicians must provide a good standard of practice and care. If they assess, diagnose or treat patients, they must: • adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary
20. We have considered Mr A’s concerns the Trust inappropriately brought forward his mother’s operation. We understand how important it was for Mr A and his mother that the Trust adhered to the original operation plan and are sorry to hear this change caused her distress.
21. We can see Ms B was admitted into the ED on 28 May with a three-week history of feeling unwell, loss of appetite and change in bowel movement frequency. The Trust carried out a CT scan on Ms B’s pelvis and abdomen which showed she had a possible perforation and inflammation of her ascending colon, overall doctors felt this was in keeping with a diagnosis of bowel cancer. The CT scan showed enlarged lymph nodes (swollen glands) around the bowel.
22. The Trust discussed the decision to operate with Ms B and Mr A on 1 June. We can see the Trust explained to Mr A at 2.59pm it may be necessary to change from an elective to emergency surgery.
23. The Trust held a multi-disciplinary meeting (MDT) to discuss Ms B’s care and decided to remove her tumour surgically. The surgery was initially planned for 20 June 2022. The Trust brought this surgery forward by a week to 13 June because of an earlier cancellation.
24. Our surgical adviser explains Ms B was admitted in the ED originally as an emergency case, meaning it was therefore appropriate to treat her with an operation to remove the tumour as soon as possible, this is in line with the GMC guidance on providing prompt investigations and treatment where necessary.
25. Our surgical adviser explains the decision to operate on 13 June was appropriate in the circumstances because there was no alternative to surgery at that time, other than palliative care (making a patient comfortable towards their end of life). They consider it is likely Ms B would have died without the surgery on 13 June. We cannot say the decision to bring forward the surgery was inappropriate.
26. Mr A explains the original plan was for Ms B to be treated at home with antibiotics until the planned surgery date of 20 June. We have requested advice to establish if treating Ms B with antibiotics for a further week would have made a difference here. Our surgical adviser explains in the circumstances treating Ms B for an additional week pre-operatively with antibiotics would not have made a difference to her condition. This is because she died from the complications of bowel ischaemia (the restriction of blood supply to the bowel) and organ failure, rather than an abdominal infection. They explain a further course of antibiotics would not have reduced her chances of dying.
27. Overall we consider the decision to bring forward Ms B’s surgery was appropriate and in line with the GMC guidance and our clinical advice supports this view.
28. We understand how important this issue is for Mr A and are sorry to hear he has concerns over the decision to bring forward his mother’s surgery. We hope our findings provide Mr A with reassurances about the Trust’s decision to bring the surgery forward.
Consent process 29. Mr A says on 13 June 2022, the Trust failed to explain to Ms B the risks of the proposed surgery, when it carried out the consent procedure for her operation.
30. The GMC guidance on consent outlines clinicians must give patients the information they want or need to make a decision. This includes: • diagnosis and prognosis • uncertainties about the diagnosis or prognosis, including options for further investigation • options for treating or managing the condition, including the option to take no action • the nature of each option, what would be involved, and the desired outcome • the potential benefits, risks of harm, uncertainties about and likelihood of success for each option, including the option to take no action.
31. We are unable to locate a copy of the consent form for the procedure on 13 June. We spoke to the Trust about this document, who confirmed it does not have a copy of a consent form. We therefore cannot say on balance the Trust completed a consent form for the procedure on 13 June.
32. The clinical records show on 1 June at 2.59pm the Trust discussed the risk of death and more common risks of the surgery with Ms B and Mr A, and on 11 June at 10.30am the Trust explained the procedure again to Ms B. We can see on 13 June at 8.02am the records outline Ms B was aware of risks of stoma, aware of risks of surgery and was happy to proceed with the surgery.
33. While this appears to outline Ms B was happy with the decision to operate and made aware of the risks, our surgical adviser explains this is not enough to constitute informed consent or indicate in detail what she was told about the risks of the surgery. We have not seen evidence to support the view the Trust properly consented Ms B for surgery on 13 June, and this is contrary to the GMC guidance on consent.
34. Having identified a failing, we have considered the impact Mr A told us this had on his mother.
35. Mr A says if his mother had known of the risks of surgery, it is likely she would not have consented. We understand how important this issue is for Mr A and acknowledge how worrying this must be for him.
36. As we explain above, the clinical records show how prior to the surgery on 13 June Trust discussed the procedure with Ms B and Mr A different occasions. The records indicate Ms B and Mr A were told of the risks of potential death and some of the more common risks of the procure.
37. We do not know the full extent of what was discussed during these conversations, on balance we think the evidence does suggest Ms B was happy with the information given and agreed with the decision to operate on her based on this.
38. We know after the initial operation on 13 June, Ms B had three further operations before she sadly died on 25 June. On each of these occasions, we can see the Trust properly completed consent forms for Ms B’s surgery.
39. During this period the records show the Trust discussed its treatment plan which involved the decision to carry out further operations with Ms B’s family. The records show on 16 June the Trust discussed Ms B’s condition with Mr A and the decision to continue to treat her, and Mr A agreed and said that his mother would want everything done to treat her.
40. We have carefully considered whether there is any evidence to suggest Ms B would not have consented for surgery on 13 June, as Mr A says. Based on the evidence, we think it is more likely than not that Ms B would still have agreed to surgery if the Trust had properly consented her before. This is because the records indicate she was happy to proceed with the operation on 13 June, and Mr A outlined to the Trust doctors during her admission that she would have wanted everything done to treat her. We have seen no evidence to suggest Ms B would not have agreed to the surgery on 13 June.
41. We cannot ever say Ms B would not have gone through with the surgery if the Trust correctly followed the consent process.
42. We do think the knowledge the Trust failed to properly consent Ms B for the surgery on 13 June would cause Mr A distress and upset. We cannot see the Trust has identified this during the complaints process. We therefore recommend the Trust apologises to Mr A for the failure to properly consent his mother and the subsequent impact this is likely to cause him.
43. As an outcome Mr A has requested service improvements to prevent this from happening again. We have also considered whether any further action is necessary. We make recommendations to remedy the impact we find has been directly caused by any failing we identify. We have seen no evidence to suggest Ms B would not have agreed to the surgery on 13 June if the Trust followed the consent process, nor do we find anything to suggest Ms B was caused any negative clinical impact because of the failing identified.
44. We have seen no evidence to raise any wider concerns about the Trust’s overall consent process for surgery, we are satisfied the Trust has appropriately followed the consent process for each of Ms B’s subsequent operations after 13 June. We think this issue relates to a one-off incident of maladministration in respect of the Trust’s record keeping during the consent process for the operation on 13 June. For this reason, we do not consider any service improvements are required in relation to the failings we have identified.
Investigations before surgery 45. Mr A says between 28 May and 13 June 2022, the Trust failed to properly examine or investigate Ms B’s abdomen before planning surgery. He says the Trust did not correctly identify the size of her tumour or that it was attached to a major blood vessel. Mr A said Dr C told him the tumour was as large as a ‘small watermelon’, which he says should have been apparent before the operation.
46. The ACP guidance outlines the local extent of colonic disease is assessed by abdominal and pelvic computed tomography (CT) to provide information on extent of spread in relation to the bowel wall and adjacent organs. Our surgical adviser explains magnetic resonance imaging (MRI) of the liver is sometimes used if abnormalities seen in the liver on a CT scan need further clarification. This can help determine whether any cancer has metastasis (where the primary colon cancer has spread to the liver) or simple cysts.
47. The clinical records show on 28 May the Trust carried out a CT of Ms B’s abdomen and pelvis. On 31 May the Trust carried out a CT of her thorax and on 6 June the Trust carried out an MRI of her liver. The results of these scans were discussed in the MDT on 10 June. We consider the Trust carried out appropriate staging investigations on Ms B prior to the MDT, when the decision was made to proceed with surgery to remove the cancer. This is in line with the ACP guidance on assessing the extent of colonic disease, and our clinical advice supports this view.
48. We have also considered Mr A’s concerns that the Trust did not correctly identify the size and location of the tumour. We acknowledge how worrying it must be for Mr A to have these concerns. We understand how important it is for him to know the Trust correctly interpreted the results prior to operating on his mother.
49. Our surgical adviser explains from reviewing the test results, there is no evidence to suggest the Trust has incorrectly identified the size or location of the tumour. The tumour was identified as ‘a bulky, largish tumour with enlarge lymph nodes which surrounded the vessels’. It is difficult to accurately clarify from the evidence without seeing the tumour itself, but the evidence suggests it was likely to be advanced based on the Trust reports. The evidence suggests the Trust correctly identified the size and location of the tumour, and our clinical advice supports this view.
Operation 50. Mr A says Dr C made mistakes during the surgery. He says Dr C • changed the operation from keyhole surgery to open surgery • cut one of Ms B’s major veins whilst trying to remove the tumour • failed to properly repair the damage to Ms B’s vein during the first operation • failed to remove all the necessary tissue during the first operation
51. The NICE guidance outlines laparoscopic resection is recommended as an alternative to open resection for individuals with colorectal cancer in whom both laparoscopic and open surgery are considered suitable. The NHS page on laparoscopy outlines that a possible complication of a laparoscopy is the need to have open surgery with a larger cut.
52. We understand Mr A’s concerns about the operation and are sorry to hear how distressing this is for him. We have sought clinical advice to help us establish if there is any evidence to suggest something went wrong with Ms B’s surgery.
53. We can see within the operation record that the Trust initially started the surgery laparoscopically, which is the standard approach in line with the NICE guidance for individuals with colorectal cancer, which the Trust assumed Ms B had at the time. The operation record outlines that during the surgery it became clear the tumour could not be removed with a laparoscopic approach, and the decision was made to convert to open surgery to complete the removal.
54. We know from the NHS page on laparoscopy it is a possible complication for surgeons to need to switch from a laparoscopy to open surgery. The clinical records show this possibility was discussed with Ms B on 1 June at 2.49pm. Our surgical adviser explains this decision to switch to open surgery was entirely appropriate in the circumstances when the tumour could not be removed using the laparoscopic approach. We consider there was no failing in the decision to change from a laparoscopic approach to open surgery, and our clinical advice supports this view.
55. We have also considered Mr A’s concerns Dr C cut a major vein during the operation which caused significant blood loss and required further operations to repair and failed to properly remove all the associated tissue.
56. Our surgical adviser explains the operation record provided by the Trust is incomplete and does appear to be missing a further page, based on this it is difficult to fully establish if something went wrong during the surgery.
57. Our surgical adviser explains unexpected significant bleeding during a procedure is not uncommon and with large tumours, tissues can tear easily due to the process of pulling on delicate vessels during the procedure. Particularly this is a known risk of operating around the duodenum (part of the small intestine) and pancreas, as was the case for Ms B’s surgery. We can see when a complication occurred, the Trust activated its major haemorrhage protocol and Dr C sought help from other surgical colleagues to assist.
58. At this stage it not possible to say that just because there was a complication, this is a sign that something went wrong during the surgery, as unexpected significant bleeding is a known risk of this type of procedure. Our surgical adviser explains there is nothing to suggest from the evidence available the procedure was not performed competently or that anything went wrong from a surgical perspective during the procedure.
59. Based on the evidence available, on balance we think it is more likely than not the procedure was carried our appropriately. We have not seen evidence there were failings in how the Trust carried out the operation Ms B had at the Trust on 13 June and our clinical advice supports this view.
Time of death and mechanical ventilation 60. Mr A says his mother died on 13 June during the surgery, and feels the Trust inappropriately kept Ms B mechanically alive for two weeks after her operation.
61. We initially considered whether there was any evidence Ms B died prior to the official notification of death on 25 June 2022 at 7.30pm. We understand how important this issue is for Mr A and how it has impacted on his ability to properly grieve his mother’s death. We are sorry to hear of this.
62. The AMRC guidance defines death as the permanent loss of the capacity for consciousness, combined with permanent loss of the capacity to breathe. This is done by a person meeting either the circulatory criteria for death or the neurological criteria.
63. The AMRC guidance explains circulatory criteria are the most common criteria used for the diagnosis and confirmation of death. This typically identified when there is an absence of breathing, the heart stopping circulation and unresponsiveness.
64. Considering the circulatory criteria, we can see from Ms B’s clinical records that daily between 13 June and 25 June, she was mechanically ventilated, her pupils were reactive, and she had an active heart rate. We consider Ms B was alive from a circulatory point of view until her recorded time of death, on 25 June at 7.30pm, and our clinical advice supports this view
65. The AMRC guidance explains neurological criteria are used to diagnose death following a devastating brain injury, confirming the permanent loss of the capacity for consciousness as well as the permanent loss of the capacity to breathe. The neurological criteria are used when death is suspected to have occurred in patients typically following a devastating brain injury who remain deeply comatose (Glasgow Coma Scale score 3 out of 15), have no observed brainstem reflexes, such as reactive pupils, and who are not breathing as their lungs are mechanically ventilated, but in whom circulation and other bodily functions persist.
66. Considering the neurological criteria, we can see from Ms B’s clinical records that between 13 June and 25 June there is no evidence to suggest Ms B lost brain function or similarly had a significant brain injury. Thereby meaning Ms B did not meet the first element of the neurological criteria for the diagnosis of death.
67. The clinical records also outline how throughout 13 June and 25 June, Ms B had reactive pupils, as she had pupils equal and reactive to light, which means she had brainstem reflexes during this time. We consider Ms B was alive from a neurological point of view until her verified time of death on 25 June, and our clinical advice supports this view.
68. Overall, there is no evidence to suggest Ms B met either clinical criterion to be defined as dead until her death was notified on 25 June. We hope this provides Mr A with reassurances over his mother’s official time of death.
69. We have also considered Mr A’s concerns that the Trust kept his mother mechanically ventilated during this period. We understand why this issue is so important for him.
70. The FCIM guidance classifies the different levels of support required for a patient in a critical carer setting. Patients who need advanced respiratory support and requiring support for multiple organ failure (such as Ms B) are categorised as being a ‘Level 3 – critical care’ patient. These types of patients require the most intensive level of care from a wide range of different clinical specialisms. It outlines patients who require mechanical ventilation should be supported by physiotherapists and dietitians to support her.
71. The clinical records show when Ms B was admitted to the ICU following her operation on 13 June, it was felt she had multi-organ failure she required mechanical ventilation, sedation, renal replacement therapy (kidney support), circulatory support (through infusions of drugs to support her blood pressure), as well as general ICU care. We can see based on this she was correctly categorised as being a Level 3 patient. This is in line with the FCIM guidance.
72. The clinical records show throughout her admission Ms B had access to and received regular physiotherapy input from the physiotherapy teams, who provided regular chest physiotherapy to support her while she was ventilated. She was seen by a dietitian to review her method of feeding and overall nutritional state, and she was provided with intravenous feeding and received electrolytes to maintain her hydration and nutrition while she was ventilated. We consider this was in line with the FCIM guidance and our clinical advice supports this view.
73. Our critical care adviser explains as she remained in severe multi-organ failure for the duration of her admission in the ICU, the mechanical ventilation was necessary in the circumstances. As Ms B had developed multiple-organ dysfunction due to the complications from her surgery and her body’s response to this. We consider Ms B was not well enough at any point during her ICU admission for her sedation to be reduced or her mechanical ventilation to be discontinued, and our clinical advice supports this view.
74. We understand how distressing it must have been for Mr A to see his mother being mechanically ventilated, and we do not underestimate the impact this had on him. We hope our explanations in respect of the decision to keep Ms B ventilated during her time in the ICU provide Mr A with reassurances over the care his mother received by the Trust. We consider there is no failing in respect of the Trust’s decision to keep Ms B mechanically ventilated, as it was clinically appropriate in the circumstances.