The Clatterbridge Cancer Centre NHS Foundation Trust

4. Mrs H’s complaint is that both WUTH and CCC delayed diagnosing and providing treatment for her husband, Mr H’s, metastatic bowel cancer.

5. She is particularly concerned that WUTH’s colorectal specialist missed signs of cancer in his May 2019 CT scan. She also complains that WUTH did not take timely action to prevent his fistula (an abnormal connection between two body parts, such as an organ or blood vessel and another structure) erupting between 3 and 19 November 2020.

6. Mrs H complains that CCC:

• did not make the results of his recent scans available at Mr H’s 2019 colorectal appointment • delayed in providing chemotherapy until two months after his surgery on 15 August • cancelled his chemotherapy and stopped face-to-face appointments on 2 April 2020 due to the risks of COVID-19 • incorrectly recorded on 30 September 2020 that Mr H was still taking tranexamic acid.

7. Mrs H also raises concerns that both Trusts caused delays in her husband’s cystoscopy being carried out due to poor communication.

8. Mrs H explained the issues she raised about the Trusts delaying diagnosing and treating her husband’s metastatic bowel cancer led to a missed opportunity for him to get more urgent treatment and him dying prematurely. She explained this has been devastating for her. She says she is unable to put into words how she felt when witnessing the progression of her husband’s illness, knowing he would be alive had both Trusts provided better care and treatment.

9. Mrs H tells us, when WUTH Trust staff did not take timely action to prevent her husband’s fistula erupting this led to:

• him having a lump protruding from his stomach that gradually got bigger through the day that eventually burst and led to him requiring a further stomach bag.

• him requiring a fistula drain, urinary sheath catheter, and leg drainage bag.

• him being bedbound and not able to walk around or sit anymore in his chair again.

• his bladder and bowel bursting which meant faeces and urine escaped out of his open wound and penis, and this was extremely painful.

• no longer receiving further treatment, only palliative care because his stoma became blocked.

10. Mrs H tells us it was devastating for her to see her husband like this.

11. Mrs H tells us, when CCC Trust’s oncologist incorrectly stated her husband was taking tranexamic acid this led to her wondering what else he may have missed about her husband’s condition or treatment.

12. By bringing her complaint to us Mrs H would like the Trusts to put service improvements in place to prevent the same from happening to other patients.

13. On 1 February 2019 Mr H’s GP referred him to WUTH due to reporting symptoms of generalised abdominal pain. He had no change of bowel habit, bleeding, or weight changes. His GP stated within the referral they wonder whether Mr H may require a colonoscopy (a procedure which uses a flexible tube with a camera on one end to look inside the rectum and colon). WUTH’s colorectal surgeon saw Mr H on 9 April. They referred him internally for a CT virtual colonoscopy, which was carried out on 1 May.

14. Mr H attended WUTH for an appointment on 15 May. The records show the consultant reviewed his scan and that this showed diverticular disease (a condition which affects the large intestine) and a peridiverticular abscess (a type of abscess which is a pus-filled cavity or lump in the tissue).

15. The consultant recorded that once the abscess resolved they would perform a flexible sigmoidoscopy (a procedure which uses a flexible, narrow tube with a light and tiny camera on one end, called a sigmoidoscope or scope, to look inside the rectum and lower colon) to ensure there was no underlying bowel tumour.

16. The consultant wrote to Mr H on 29 May to explain they would drain the abscess. However, this happened spontaneously a few days later so no drainage was performed.

17. Mr H next attended WUTH on 28 June. A colorectal and general surgeon recorded that a colo-vesical fistula had formed (this is an abnormal connection between the colon and urinary bladder) and that he needed surgery to treat this. They also requested a flexible sigmoidoscopy on this date to further assess him for cancer. In a follow-up letter to Mr H’s GP, they explained that it was important to check for sigmoid (left side of the bowel) cancer (since the initial CT cannot exclude this). WUTH also arranged for a CT scan of his chest and upper abdomen.

18. On 30 July, WUTH confirmed Mr H’s cancer diagnosis, as the sigmoidoscopy found a tumour in his sigmoid colon. A multi-disciplinary team meeting agreed he should have a laparotomy bowel resection (this removes the damaged or diseased portion of the bowel), ureteric extended as well as bladder resection, and a colostomy (surgery to create an opening for the colon through the abdomen).

19. This surgery took place at WUTH on 15 August. The records show the tumour was completely removed but that the margins of one lymph nodes were positive for cancer. He was assessed at follow-up appointments through September.

20. On 26 September, WUTH decided to refer Mr H for neoadjuvant chemotherapy (chemotherapy after surgery) to reduce the risk of further metastatic spread.

21. On 5 October, a consultant in clinical oncology at CCC assessed Mr H. They offered him adjuvant chemotherapy with Oxaliplatin (medication to treat cancer) and 5FU (FOLFOX regimen, which means a combination of chemotherapy drugs) for 12 cycles over six months. They recorded they would amend the treatment plan if further scans showed more aggressive cancer.

22. Mr H had a CT scan at CCC. This showed possible spread of cancer to his liver. The oncologist put his chemotherapy on hold pending an MRI scan to investigate this further. The MRI on 18 October confirmed the presence of five cancerous lesions in the liver.

23. Mr H had a PET scan at CCC on 22 October which showed he had incurable/inoperable metastatic disease. The oncologist amended his chemotherapy to a more aggressive regimen used to treat cancer which has spread.

24. On 24 October Mr H started chemotherapy.

25. On 2 April 2020, an oncologist from CCC called Mr H to discuss the risks of COVID-19 infection. They explained they recommended putting his chemotherapy on hold due to him being immunosuppressed and potential life-threatening consequences. They arranged to assess him again in two months to re-evaluate the situation and repeat a CT scan.

26. On 3 June, Mr H had a telephone consultation with a CCC oncologist who recorded that he was asymptomatic and remained well, despite being off chemotherapy. He had a further CT scan on 22 June, which unfortunately showed his cancer had progressed, including to the bladder wall.

27. During a further telephone consultation on 24 June, the records show Mr H had increased urinary frequency and was keen to start chemotherapy. On 6 July CCC arranged an appointment for Mr H to start chemotherapy.

28. On 3 September, an oncologist at CCC wrote a letter to WUTH. This explained Mr H was awaiting a ‘flexible sigmoidoscopy’, but also explained he was awaiting a ‘flexible cystoscopy’. The letter was later amended to make clear that he was waiting for the latter. A further letter from the CCC oncologist on 30 September explained he was taking tranexamic acid.

29. On 3 November, Mr H had a cystoscopy and transurethral resection of his bladder tumour. On 11 November, a stoma care specialist nurse at WUTH assessed Mr H and noted his fistula had opened up and had small bowel content coming out of it. On 16 November, Mrs H phoned WUTH informing them Mr H had a pouch leak and fistula had changed size.

30. Mr H sadly died on 18 December 2020.

WUTH Trust

Delays in diagnosis and treatment

34. Mrs H explained that WUTH delayed in diagnosing Mr H’s bowel cancer. She feels its colorectal specialist may have missed signs of cancer in his May 2019 CT scan and that this meant he was prevented from receiving urgent treatment as soon as he could have.

35. We recognise the immense distress Mrs H experienced and how difficult this time was for her and Mr H.

36. In its complaint response, WUTH explained that Mr H’s GP referred him on a routine pathway and that it saw him within the recommended timeframe. It explained that it then arranged diagnostic investigations and started treatment again within recommended timescales.

37. WUTH acknowledged that the overall diagnostic and treatment process took several months, and it appreciated this may have been frustrating for Mr and Mrs H. It explained this was because of the complex nature of his symptoms.

38. In order to understand whether WUTH handled Mr H’s care properly, we first need to understand what the relevant guidelines say should happen.

39. DoH guidance states that when a patient is referred on a routine pathway, they should be seen within 12 weeks and their treatment started within 18 weeks.

40. GMC guidance (paragraph 15) also states that doctors must provide a good standard of practice and care. It states ‘if you assess, diagnose or treat patients, you must: a) 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 b) promptly provide or arrange suitable advice, investigations or treatment where necessary c) refer a patient to another practitioner when this serves the patient’s needs’.

41. We can see from the records that Mr H’s GP referred him on a routine pathway on 1 February 2019 (as opposed to an urgent two-week pathway for possible cancer). As such, WUTH needed to see him by 26 April (12 weeks later) and start any treatment by 7 June (18 weeks later).

42. WUTH’s colorectal surgeon first saw Mr H on 9 April 2019. This is within the timeline specified by DoH guidance. The consultant referred Mr H for a CT colonography scan, which took place on 1 May.

43. Our colorectal adviser explained that this was the right thing to do, as it was unclear what was causing Mr H’s symptoms, and as it was arranged without delay. We therefore consider that the consultant acted in line with GMC guidance (15b and c) in arranging further investigations.

44. Following the CT scan, Mr H had a further appointment on 15 May. The records show the surgeon reviewed the scan results and identified diverticular disease and a peridiverticular abscess.

45. We asked our colorectal adviser whether they feel the surgeon missed signs of bowel cancer in the scan. Our adviser reviewed the scans and report and explained that it does not appear the surgeon missed any signs of cancer. They explained that the surgeon assessed Mr H appropriately and in line with GMC guidance 15a, and that their decision to try and drain the abscess before performing a sigmoidoscopy was clinically appropriate, and in line with GMC guidance 15b.

46. On 31 May, WUTH started treatment to drain the abscess but found that it had already discharged. This shows it tried to provide treatment within the timeframes specified by DoH guidance.

47. Mr H next attended WUTH on 28 June. The colorectal/general surgeon found that a colo-vesical fistula had formed (this is covered in more detail below) and arranged for a flexible sigmoidoscopy to try and exclude sigmoid cancer. Our colorectal adviser explained this took place within two weeks on 12 July. It showed a probable cancerous lesion in Mr H’s sigmoid colon. We consider this is in line with GMC guidance which says to promptly arrange investigations, as the flexible sigmoidoscopy took place within two weeks, and have not seen any unavoidable delays which took place.

48. WUTH then performed a CT scan of Mr H’s thorax on 16 July. It confirmed his diagnosis on 30 July. Clinicians discussed his case in a multidisciplinary team meeting and decided he should have the cancerous part of the bowel removed, as well as a colostomy. This took place on 15 August.

49. Our colorectal adviser explained that this surgery would have only been for symptom control, as his cancer had spread by this point and was not curable. They gave their view that WUTH treated Mr H in line with GMC guidance (15).

50. WUTH assessed Mr H again on 16 September, and decided to refer him for neoadjuvant chemotherapy on 26 September.

51. Considering the available evidence and advice received, we cannot see that WUTH failed to provide Mr H with prompt assessment, investigations, and treatment. Its actions were in line with DoH and GMC guidance and that it did not cause unnecessary delay or miss signs of cancer.

Fistula

52. Mrs H says she feels something could have been done (such as drainage) to prevent Mr H’s fistula erupting between 3 and 19 November 2020. We are very sorry to hear about the significant impact this had on her and Mr H.

53. In its complaint response, WUTH explained fistula was a direct consequence of the re-occurrence of his cancer and could not have been prevented. It did not directly address the complaint that more should have been done to prevent it erupting.

54. As above, GMC guidance (paragraph 15) explains how doctors must assess patients thoroughly, and provide prompt investigations and treatment.

55. Mr H’s medical records from 11 November show that his fistula had erupted. A stoma care specialist nurse recorded ‘seen patient today. Noticed that his fistula has opened up and having small bowel content coming out of it’.

56. The records show that, at this point, Mr H’s cancer had spread to his liver, colon, bladder, and abdominal wall. A further note from the same day states:

‘we explained we could consider bringing out another stoma higher up than the site of the perforation to help control the output of the fistula but this is a major operation and may not be possible with peritoneal disease (a cancer that begins in an organ within the abdomen and spreads to the peritoneum, the peritoneum is the sheet of smooth tissue that lines the abdomen wall and covers most of the organs in the abdomen). We emphasised that he has an acute problem on top of his long-term cancer which he knows is not curative’.

57. A multidisciplinary team met to discuss his case that day. Records from 14 November detail that staff were monitoring his condition and taking action to change his fistula bags.

58. We asked our colorectal adviser for their view on whether WUTH treated Mr H’s fistula correctly.

59. Our adviser explained that Mr H’s fistula erupted spontaneously. They explained this is often the case and there is no way to stop this. They confirmed that because Mr H was so unwell, it would not have been appropriate for him to have further surgery. They gave their view that WUTH acted in line with GMC guidance in the way it treated/monitored his condition.

60. Considering the available evidence and advice received, we consider WUTH could not have done anything further to prevent Mr H’s fistula erupting. However, we recognise the significant distress this event caused both Mr and Mrs H at what was already an extremely difficult time.

CCC Trust

Scan availability at appointments

61. Mrs H says the PET scan results from 22 October 2019 were not available during Mr H’s colorectal appointment at CCC on 24 October. She feels this may have delayed diagnosis and prevented him from receiving more urgent treatment.

62. In its complaint response, CCC explained the PET CT was done on 22 October and reported late afternoon on 23 October. It said it reviews results as they are made available on its reporting system. It said unfortunately, this was not in time for Mr H's clinic review on 24 October.

63. It explained the scan results would not have changed his treatment plan. It explained the results were discussed at the Colorectal MDT meeting on 25 October, and the Oncology MDT on 31 October; both of which agreed his treatment plan.

64. We consider that the scan results were available on the system on 23 October, but the consultant was unable to review the results in time for Mr H’s appointment and wanted to discuss the results in MDT meetings. We can see that cycle one of FOLFOX chemotherapy still went ahead on the same day (24 October) and the results from an MRI on his liver on 18 October were discussed.

65. Our Principles of Good Administration state ‘public bodies should give people information and, if appropriate, advice that is clear, accurate, complete, relevant and timely’. We consider that the consultant did inform Mr H that the results were not yet available, and explained they will review the results in the MDT meetings on 25 October and 31 October.

66. The medical records detail that, by 15 October, CCC clinicians were already aware that Mr H’s CT and MRI scans showed the cancer had spread to his liver. It made the decision to proceed with chemotherapy based on these results.

67. We asked our oncology adviser for their view on whether Mr H’s diagnosis or treatment might have been different if the scan results had been available on 24 October. Our adviser confirmed that this did not in any way delay his diagnosis or treatment. They explained that the decision to proceed with chemotherapy had already been made and would not have made any difference.

68. We therefore consider that there would have been no impact if the consultant had had the chance to review the results before the appointment on 24 October, and is understandable they wanted to review the results in an MDT meeting before discussing them with Mr H.

Delays in chemotherapy

69. Mrs H complains that CCC delayed in providing Mr H with chemotherapy until two months after his bowel surgery on 15 August 2019.

70. In its response, CCC explained Mr H needed time to recover from his surgery before he could start chemotherapy. It explained it waited a ‘clinically appropriate’ amount of time following surgery.

71. The records show us that after WUTH’s consultant referred him, Mr H was first seen by CCC on 5 October for consideration of adjuvant chemotherapy (with an intent to cure).

72. Our oncology adviser explained that NHS guidance on good practice for consultant-to- consultant referrals does not specify waiting times for assessment. They explained however that NICE guidance [CSG5] says adjuvant chemotherapy should usually start within six weeks of surgery.

73. Although Mr H started chemotherapy on 24 October, outside of this timeframe, our adviser explained the significance of his scans in changing the treatment plan and the type of chemotherapy he needed. They explained that because the cancer was found to have spread to his liver on 15 October, the intent of treatment needed to change from curative to palliative.

74. As such, they explained that the above NICE guidance no longer applied. They explained that it would still be good clinical practice to start palliative chemotherapy as soon as possible and that they felt CCC did this (it started the treatment within two weeks of the diagnosis changing).

75. In summary, we consider CCC acted in line with GMC guidance (paragraph 15) in the way it scheduled and arranged Mr H’s chemotherapy. It arranged a different treatment when this became necessary and did so promptly.

Chemotherapy and face-to-face appointment cancellation

76. Mrs H complains CCC’s oncologist cancelled Mr H’s chemotherapy and stopped face-to-face appointments on 2 April 2020 due to the risks presented by COVID-19. She explained he should have been offered the option to continue treatment and accept the risks.

77. In responding to the complaint, CCC explained it took several measures in an attempt to reduce the transmission to protect clinically vulnerable patients. It said, these measures include reducing the number of face-to-face appointments and amending them to telephone consultations where it is safe to do so. It said this was based on the recommendations of National Health Service England (NHSE) guidance.

78. We have reviewed the medical notes, and can see that on 2 April 2020, there is a letter from the oncologist at the Trust which states:

‘in view of the current outbreak of COVID-19 infection, I have recommended putting his chemotherapy on hold to reduce the risk of immunosuppression and virus contraction which could have life threatening consequences. I have arranged to see him again in two months’ time on 3 June 2020 to re-evaluate the situation’.

79. The records show Mr H’s chemotherapy did not start again until 6 July, over three months later.

80. In considering whether CCC was correct to cancel his chemotherapy and face-to-face appointments, we looked at what local and national guidelines said at the time.

81. The SRG Guidelines during COVID-19: NHSE Clinical Guide for Cancer Patient Management (approved on 17 March 2020, the review date of this policy was July 2020) stated on page eight at point eight, ‘consider treatment breaks for long-term treatments when risk of coronavirus is high’.

82. The National Library of Medicine published an article in 2020 explaining that cancer patients were regarded as a highly vulnerable group to weakened immune systems caused by both tumour growth and anti-cancer treatment.

83. Further SRG Guidelines from this early stage of the pandemic stated that the ‘default for all follow ups should be telephone consultation unless the patient needs to come for clinical examination or consenting.’

84. The guidance sets out the different priority levels for patients at the time. Our oncology adviser gave their view that Mr H would have been level four as per these guidelines. Priority level four explains where curative therapy has a very low (below 10%) chance of success, adjuvant (or neo) therapy which adds less than 10% chance of cure to surgery or radiotherapy alone or treatment given at relapse, or where the therapy is non-curative with an intermediate (15 – 50%) chance of less than a one-year life expansion.

85. We consider Mr H would have been level four because we can see a PET scan in October 2019 confirmed Mr H had incurable/inoperable metastatic disease. As such, our adviser explained that CCC were correct to pause his chemotherapy.

86. Regarding not offering Mr H a face-to-face appointment from 2 April, we have reviewed the records and can see that his consultations were via the telephone instead of face to face. This appears in line with the SRG guidelines which stated this should be the default at the time.

87. We consider it was clinically appropriate to put Mr H’s chemotherapy on hold in line with the guidance, and can see within the notes, whilst his chemotherapy was put on hold, on 3 June he was reported to be remaining well and asymptomatic. He had had no chemotherapy for three months at this stage. We consider, as our adviser explained, the Trust were correct in pausing Mr H’s chemotherapy. We consider the risks would have outweighed the benefits of him being seen face to face during this time.

88. In summary, we consider CCC followed COVID-19 guidance by holding consultations remotely and by pausing his chemotherapy. We understand this to have been a very distressing time for Mr H and can recognise why Mrs H has raised concerns. We understand why face-to-face appointments were preferred.

Tranexamic acid

89. Mrs H raised concerns that within a letter dated 30 September 2020, the oncologist stated that Mr H was taking tranexamic acid (a medicine which controls bleeding) since discharge. She says this caused her concern, wondering what else may have been missed about Mr H’s condition or treatment.

90. In its response, CCC explained the oncologist referred to tranexamic acid based on the acute oncology note on the electronic system and apologised for the inaccuracy. It said it had received a discharge summary report from WUTH Trust and it did not mention tranexamic acid treatment had been stopped. It explained its oncologists are not routinely updated if non-oncological medications started and stopped in other healthcare settings.

91. GMC guidance at paragraph 19 says documents (including clinical records) should be ‘clear, accurate and legible’.

92. We have reviewed the 30 September letter and can see it does state ‘he is currently on tranexamic acid and he has had no further bleeding since discharge from hospital’.

93. CCC has acknowledged this information was not accurate and apologised for this. We understand why it would have been concerning for Mrs H. We can also see how WUTH not informing CCC Mr H was no longer taking tranexamic acid might have contributed to this.

94. We consider this was not in line with GMC guidance as the records were inaccurate. We asked our oncology adviser whether this inaccuracy would have had any impact on Mr H’s treatment. They explained that this information would not have been a deciding factor in the decision to withhold chemotherapy.

95. We can also see that once the error was recognised, this was corrected shortly after. We have also not seen any evidence to suggest Mr H took tranexamic acid when he should not have.

96. Level one on our Severity of Injustice Scale states cases will be level one where ‘the person affected has experienced a low impact injustice such as annoyance, frustration, worry or inconvenience, typically arising from a single (one-off) incidence of service failure.’ We usually consider an apology to be an appropriate remedy.

97. As the Trust has apologised for the error, corrected it shortly after, and there was no clinical impact, we consider we will not take any further action on this part of the complaint.

Both Trusts causing delays in cystoscopy

98. Mrs H raised concerns that both Trusts caused delays in Mr H’s cystoscopy being carried out. She says some letters indicated he had been incorrectly listed for a sigmoidoscopy, and doctors did not communicate between themselves about who was dealing with the booking of the test. Mrs H tells us this led to a delay in the cystoscopy being carried out.

99. CCC apologised for the typographic error in the summary box and postscript (PS) section of the letter. It said the correct procedure was named in the body of the letter. It noted Mr H brought this to staff attention during his next consultation, it corrected the error, and sent an amended version of the letter to Mr H. It explained this did not have any impact on his care, as the cystoscopy had already been planned on 18 August 2020.

100. WUTH acknowledged noted there was a letter within the oncology correspondence containing a typing error stating ‘sigmoidoscopy’ rather than ‘cystoscopy’. It explained Mr H was not listed for a sigmoidoscopy. It explained the typing error did not result in any delay, and the correct referral was made by its urologists.

101. We can see that both Trusts agree there was an error and that the wrong procedure was detailed in correspondence. Our review of the records also shows that this was the case. It appears that CCC was responsible for this error as it was its letter to Mr H’s GP which incorrectly stated he was awaiting a flexible sigmoidoscopy. This was later corrected

102. As previously stated, GMC guidance at paragraph 19 says documents (including clinical records) should be ‘clear, accurate and legible’. We consider that this was a shortcoming of GMC guidance and does not fall so far below the standard expected to amount to a service failure.

103. From reviewing the records, we have not seen any evidence that this error caused a delay in him receiving a cystoscopy. Our oncology adviser explained it would have been clear to WUTH’s urologists that it was an error and that it did not cause any delay. The records show us that the correct procedure was booked despite the typographical error.

104. We therefore consider this was a minor error, which we do not consider amounts to a service failure. We also can see it had no clinical impact. We will therefore take no further action.

105. We have not found any evidence to suggest the care and treatment Mr H received from both WUTH Trust and CCC Trust fell below the expected standards to amount to a service failure.

106. We are very sorry to hear of the sad loss of Mr H and do not wish to underestimate how distressing this time was for him and his family.

1. We have carried out an investigation into the care and treatment Mr H received. We are very sorry to hear of the sad loss of Mr H as well as the events that led to Mrs H bringing the complaint to us. We understand this to have been a very difficult and distressing time for both her and her family.

2. After receiving clinical advice and reviewing the evidence available to us, we have not found that either WUTH or CCC failed to follow guidance in the treatment provided.

3. We have therefore decided not to uphold the complaint about either Trust.