The Christie NHS Foundation Trust

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

11. Mr P complains about the care his late wife, Mrs C received at Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust (WWLFT) during 2021.

12. Mr P specifically complains that:

• The Trust only carried out ‘visual checks’ during follow up appointments in June and October 2021 following successful treatment of aggressive endometrial cancer.

• When Mrs C went to the Emergency Department (ED) on 14 November 2021 with severe stomach pain, a ‘blockage’ and infection was suspected, however, she was sent home with only anti-biotics and laxatives. Mr P says that his wife’s medical history was not taken into consideration and the cause of the blockage was not appropriately investigated or treated.

13. Mrs C was later diagnosed with a large cancerous mass in her stomach. Mr P feels this should have been found sooner if more thorough checks had been carried out. He says his wife wouldn’t have been left in pain and the infection could have been treated had further investigation been carried out when she visited the ED on 14 November 2021.

14. Mr P says he and his two sons have been devastated by his wife’s death and this will have a long-lasting effect on them.

15. Mr P is looking for service improvements, acknowledgments and apologies.

The Christie NHS Foundation Trust

16. Mr P complains about the care his late wife, Mrs C received at The Christie NHS Foundation Trust (the Christie) whilst undergoing cancer treatment during 2021.

17. Mr P specifically complains that:

• The Christie recommended visual follow ups following successful treatment of aggressive endometrial cancer. Mr P says additional monitoring and investigation should have taken place.

• During an inpatient stay from 6 December 2021 to 31 December 2021 the Christie were not able to identify and control an infection which led to sepsis.

18. Mr P says that additional monitoring during follow up appointments, such as scans, may have detected Mrs C’s reoccurrence of cancer sooner and enabled a chance of treatment. He also says if the infection had been identified and treated sooner this would have increased her chances of treatment for the recurrence cancer which was diagnosed shortly after her admission.

19. Mr P says he and his two sons have been devasted by his wife’s death and this will have a long-lasting effect on them.

20. Mr P is looking for service improvements, acknowledgments and apologies.

21. Mrs C was diagnosed with an aggressive form of endometrial cancer (a cancer of the womb) in 2020. On 26 October 2020 Mrs C had a hysterectomy (removal of the womb) at the Christie.

22. Following the hysterectomy, Mrs C underwent adjuvant brachytherapy treatment, which is a type of internal radiotherapy treatment usually given as part of endometrial cancer treatment. This was completed in January 2021.

23. Mrs C was seen at WWLFT for follow up appointments in June and October 2021. In the October appointment concerns were noted and a vaginal biopsy was arranged. A CT scan was carried out on 19 November. This was reported on 29 November and showed recurrent grade three cancer.

24. Mrs C was due to attend an outpatient appointment at the Christie on 6 December 2021 to discuss treatment options and was admitted on the same day.

25. During the same period, Mrs C was diagnosed with an intra-abdominal infection, which had caused sepsis. She was also diagnosed with acute kidney injury.

26. Mrs C was treated with antibiotics but sadly died on 31 December 2021 after her condition deteriorated.

WWLFT

Follow ups for cancer treatment in June and October 2021

32. Mr P is concerned WWLFT only carried out visual checks of his wife during follow ups appointments in June and October 2021. Mr P feels scans or biopsies should have been carried out given the severity of her cancer.

33. Following the completion of brachytherapy treatment in January 2021, the Christie arranged a follow up for Mrs C in the gynaecology clinic at WWLFT for 28 June 2021.

34. During the appointment in June, Mrs C had a visual examination and it was noted Mrs C was feeling well and there were no signs of reoccurrence and a further routine follow up appointment was made for six months’ time.

35. Mrs C was seen again in the outpatient gynaecology clinic at WWLFT on 21 October 2021. During this appointment Mrs C reported some vaginal spotting and she had another visual examination. The doctor noted a ‘raw area’ at the top of the vagina and arranged a biopsy for further investigation.

36. The SGO recommends physical examination, including bimanual (an internal examination using the hand) recto-vaginal examination, which has been reported as more effective than vaginal cytology (microscopic inspection of cells), laboratory testing, or imaging to detect recurrence of gynaecologic cancers.

37. The SGO also recommends computed tomography (CT) or positron emission tomography (PET) scans if recurrence of a gynaecologic cancer is suspected following a visual examination and reported symptoms.

38. Our oncology adviser explained no routine imaging is recommended to monitor patients following completion of treatment for endometrial cancer. They added visual checks are a more effective way of detecting recurrent cancer than biopsies, laboratory tests or imaging.

39. We can see a biopsy was arranged for 11 November 2021 following the visual check up and Mrs C’s reporting of vaginal spotting in October.

40. Our gynaecology adviser explained in the absence of more generalised symptoms, such as finding an abdominal mass on examination, it would be reasonable to wait for biopsy results before arranging further investigation such as scans.

41. We have found WWLFT carried out both examinations in line with guidance and arranged for further investigation when changes were noted during the visual examination. We hope to reassure Mr P no further tests or investigation should have been carried out sooner.

Treatment in the ED on 14 November 2021

42. Mr P complains WWLFT did not fully assess or investigate the causes of his wife’s severe stomach pain when she attended the ED on 14 November 2021.

43. Mrs C attended Leigh Walk in Centre in the morning of 14 November with severe abdominal pain and a reduced appetite. She was advised to attend the ED for further assessment.

44. When Mrs C attended the ED at WWLFT she complained of fever and severe abdominal pain which had become worse. WWLFT noted her history of cancer and the treatment she had for it, including the hysterectomy. It also noted she had a biopsy following vaginal spotting a few days prior to her attendance.

45. The records show Mrs C had a high temperature of 39.3 degrees, a heart rate of 119 and fast breathing. WWLFT took her bloods and tests showed she had raised inflammatory markers (which can indicate infection), a neutrophil count (a test to look at white blood cell levels, which is used to indicate the risk of infections) of 9.2 and a C-reactive protein (CRP, which is a test for proteins in the blood and can indicate infection) count of 249. All of these markers were consistent with Mrs C suffering from an infection.

46. To investigate the source of the infection, Mrs C had a chest and abdominal X-ray on the same day which showed clear lungs, but some faecal loading (constipation).

47. After assessment and the X-ray, WWLFT diagnosed Mrs C with sepsis, likely from an infection in the abdominal area. Doctors were unclear about where exactly the infection had originated.

48. In view of the recent vaginal bleeding and biopsy, Mrs C was also seen by a gynaecologist, who felt the infection was unlikely to have been of a gynaecological origin. At this stage, Mrs C was diagnosed with likely sepsis from an infection of unknown origin.

49. Sepsis is a reaction to an infection and can be life-threatening. Our physician adviser told us sepsis is characterised by fever, fast heart rate, rapid breathing and body pain. Mrs C was showing all of these symptoms on 14 November.

50. NICE guidance on the management of suspected sepsis says broad spectrum antibiotic treatment should be given when the source of the infection is unknown. It goes on to say once the source of the infection is confirmed, more specific antibiotics may be given.

51. In Mrs C’s case, the exact source of the infection was unknown, so WWLFT prescribed intravenous (IV) piperacillin with tazobactam on 14 November, which is a broad-spectrum antibiotic.

52. BNF guidance on piperacillin with tazobactam says this antibiotic should be used in patients with suspected sepsis.

53. We are have found WWLFT treated Mrs C’s suspected sepsis in line with the relevant guidance when it could not find the exact source of the infection.

54. We can see the plan was to treat the suspected sepsis whilst also investigating the source of the infection. A CT scan was planned.

55. On 15 November after staying in hospital and receiving further doses of IV antibiotics, Mrs C reported feeling better. The records show she was sat in a chair and drinking. By this stage her vital signs, including her heart rate and oxygen levels were back within normal parameters.

56. The records show Mrs C was reviewed by a consultant who noted Mrs C’s abdomen was soft and non-tender. The consultant’s impression was that Mrs C had an intra-abdominal infection and constipation. In view of Mrs C’s overall improvement the plan was to cancel the CT scan and discharge Mrs C with co-amoxiclav (a broad spectrum antibiotic), to be taken orally, laxatives and anti-sickness medication.

57. There are no specific guidelines that cover indications for CT imaging in patients with fever or abdominal pain. However, our physician adviser explained whilst the decision to discharge Mrs C was based on her significant clinical improvement, after considering her history and combination of symptoms, it would be usual practice to consider investigation for the source of the intra-abdominal infection.

58. Our physician adviser also told us a CT or ultrasound of Mrs C’s abdomen would have been expected prior to discharge to clarify the source of the infection and ensure no further treatment or medication was needed.

59. NICE guidance on the management of sepsis says imaging of the abdomen and pelvis should be considered if there is no definite source of infection after clinical examination and initial tests.

60. In addition, GMC good medical practice says doctors should take account of patient’s history and arrange investigation where necessary.

61. We have seen WWLFT discharged Mrs C without carrying out imaging in the form of a CT scan or ultrasound, as planned, to investigate Mrs C’s symptoms and the source of sepsis after considering her history. It did not carry out further investigation to come to a more specific diagnosis and did not explain why the plan had changed. We find this to be a failing.

62. We have thought about the impact of this failing and can see Mrs C attended WWLFT on 19 November with similar symptoms. At this stage a CT scan was carried out. This CT scan confirmed recurrent cancer and a large mass was found. Mrs C was referred back to the Christie, but as we have gone on to consider below, treatment options were limited.

63. We have noted the CT scan was delayed by three days and Mrs C could have had the CT scan whilst an inpatient during her admission which started on 14 November. However, we do not know when the scan would have been carried out during that admission. Our physician adviser told us the CT scan during this admission would have been dependent on local availability and therefore, we cannot say for certain when exactly it would have been carried out. Furthermore, our oncologist adviser explained no decisions about how to potentially treat the recurrent cancer would have been made until the multi-disciplinary meeting which happened on 26 November 2021. Therefore, we cannot say having a scan sooner would have changed the outcome for Mrs C.

64. Whilst the outcome may not have been different for Mrs C, we think the failing we have found could impact others and we have gone on to explain what recommendations we have made the end of this report. We hope this will give some reassurance to Mr P.

The Christie

Follow ups following treatment of endometrial cancer

65. Mr P says the Christie should have recommended WWLFT carry out more than visual examinations when his wife’s cancer had been treated.

66. As mentioned in paragraph 30, following the treatment of Mrs C’s cancer in January 2021, the Christie referred Mrs C to WWLFT for follow up treatment as an outpatient.

67. The records show the Christie called Mrs C six weeks after her adjuvant brachytherapy treatment on 19 February 2021. During this call the Christie explained Mrs C had been discharged from its care and a follow up appointment was made at WWLFT for June. A letter was also sent to Mrs C with this information.

68. The SGO says patients with stage 1A grade 1 or 2 endometrial cancers should be seen every six months for the first year following treatment. Our oncologist adviser said Mrs C fell into this category after her adjuvant brachytherapy treatment.

69. We have also explained the SGO’s guidance on what should happen during the follow up appointments in paragraphs 33 and 34, where we have seen it recommends visual follow ups.

70. Having looked at the timing of the follow up appointments, we can see the Christie followed up with Mrs C during a telephone appointment and she was referred to be seen by WWLFT within six months of completing her treatment.

71. We also found the Christie arranged a suitable follow up via telephone call, then at WWLFT within the recommended timeframe and we hope this reassures Mr P.

Treatment of infection between 6 and 31 December 2021

72. Mr P raised concerns the Christie did not do enough to identify where the infection source was and control it when his wife was admitted on 6 December 2021.

73. Mrs C was seen in an outpatient clinic at the Christie on 6 December 2021 following the diagnosis of recurrent grade 3 endometrial cancer. During this appointment treatment options were discussed and it was decided to go ahead with chemotherapy.

74. On the same day, Mrs C was admitted to the Christie following the appointment because of high creatinine levels (an indication of kidney injury). Mrs C was at risk of hydronephrosis (enlarged kidneys which cannot drain urine efficiency) because of the cancerous mass in her pelvis. The plan was to carry out an ultrasound scan, insert a nephrostomy tube (to drain the kidneys) and then start chemotherapy treatment.

75. Our oncologist adviser explained this was necessary as it is too dangerous to start chemotherapy with kidney injury because this would lead to complete kidney failure and potentially death.

76. A urine sample was collected on 7 December, which grew E.coli, which is a bacterial infection which can cause severe diarrhoea, stomach pain and kidney failure and usually grows from urinary tract infections (UTI). Mrs C was treated with ciprofloxacin.

77. The BNF says ciprofloxacin should be used to treat UTIs in adults.

78. On the same day, Mrs C was told her kidney function was not yet good enough to start chemotherapy because the cancerous mass had grown and was putting pressure on her kidneys. The records show Mrs C agreed to keep treating the kidney failure before proceeding with chemotherapy.

79. Mrs C had the nephrostomy tube inserted on 13 December and remained relatively well for the next few days. However, on 16 December, her temperature spiked, which could be a sign of infection. The records show her bloods were taken to check CRP levels, however at that stage Mrs C looked and remained clinically well and the plan was to continue monitoring her, specifically to look for signs of infection. If Mrs C remained well the plan was to start chemotherapy as soon as possible.

80. On 17 December, Mrs C’s bloods were reviewed which showed increased CRP levels, indicating an infection. At this stage the infection source was unknown and Mrs C was treated with IV menopenum.

81. The BNF says to treat suspected hospital acquired sepsis with menopenum. At this stage, in line with the sepsis guidance, we have found the Christie treated the infection with another broad-spectrum antibiotic as the source of the new infection was unknown.

82. A CT scan was carried out on 19 December to investigate the source of the infection. This is in line with the NICE guidance on sepsis mentioned above.

83. During the same day, Mrs C was reviewed and her temperature was increasing. Doctors decided to continue with IV gentamicin (another broad-spectrum antibiotic used to treat sepsis) to treat the infection and suspected sepsis and discuss further.

84. On 20 December Mrs C was seen again and whilst she was still unwell, the records show a clear plan to treat the infection and sepsis then start chemotherapy. However, it was also noted chemotherapy was too risky at that point and the cancer was progressing.

85. By 21 December, Mrs C’s renal function had normalised, but her temperature was continuing to spike and she began to feel more unwell. She continued to receive antibiotics to treat sepsis.

86. We have seen evidence doctors at the Christie had regular discussions with microbiologists at the Christie to consider what antibiotics may be most effective in treating the infection which was worsening.

87. We can also see the Christie continued to look for the source of the infection by carrying out CT scans, X-rays and blood tests.

88. On 25 December, Mrs C was diagnosed with clostridium difficile (C.diff), which is a bacteria that can caused diarrhoea, especially in people who have taken large amount of antibiotics. It was jointly decided by Mrs C and doctors to wean down antibiotics to treat the C.diff and aim for chemotherapy.

89. Mrs C continued to experience peaks in her temperature and doctors decided to treat sepsis as a priority and she was prescribed IV piperacillin with tazcotin again. Doctors were also still treating the C.diff.

90. Over the next few days Mrs C’s condition was variable but she began to deteriorate rapidly on 29 December. Following reviews of recent CT scans, it was decided that the cancer had progressed and because of the sepsis, Mrs C would be unable to receive chemotherapy and instead, she would receive supportive treatment.

91. On 30 December, whilst Mrs C was noted as comfortable, the records show staff thought she was nearing the end of her life and discussed this with her. It was agreed to make Mrs C comfortable and proceed with end-of-life care. Mrs C’s priority was to see her husband and two sons, and this was arranged.

92. Sadly, Mrs C continued to deteriorate, and she died on 31 December 2021.

93. GMC good medical practice says doctors should consult colleagues and refer patients to suitably qualified practitioners where it suits their needed.

94. The same guidance says doctors must give clear and accurate information to patients and explain their condition and options for managing it.

95. We have found the Christie continuously tried to look for the source of Mrs C’s ongoing infection after 16 December when it was diagnosed. It also sought advice from other areas of expertise when thinking about how to treat the infection.

96. We also hope Mr P will be reassured that we have seen evidence the Christie communicated with his wife, and she was aware and in agreement with treatment she received throughout this admission.

1. We have carefully considered Mr P’s complaint about the care his wife, Mrs C received at The Christie NHS Foundation Trust (the Christie) and Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust (WWLFT) during 2021.

2. We thank Mr P for telling us about his complaint and we know this was an extremely distressing time for him and his family.

3. We found WWLFT and the Christie carried out follow up examinations in June and October 2021 in line with relevant guidance following Mrs C’s cancer treatment.

4. We have seen WWLFT treated Mrs C’s suspected sepsis during an admission in November 2021, however it did not carry out a CT scan as planned when it could not find a specific cause of the sepsis.

5. We found the Christie tried to investigate the causes of Mrs C’s infection during her admission in December 2021 and also treated it in line with guidance.

6. We therefore partly uphold Mr C’s complaint about WWLFT.

7. We think the failings we have identified here did not affect the overall outcome for Mrs C, but knowing a CT scan did not take place when it should have been considered will cause distress for Mr P.

8. We are not likely to uphold Mr P’s complaint about the Christie.

9. We have set out the reasons for our current thinking under headings below, for clarity.

10. Our main headings match the areas of focus as outlined in the scope of Mr P’s complaint outlined on pages 2 and 3. We have considered the specific issue about each Trust separately and listed them under headings. Under each heading we have explained our provisional view.