Norfolk and Norwich University Hospitals NHS Foundation Trust

4. Miss R complains about how the Trust managed her ongoing issues with gallstones, and an elective laparoscopic cholecystectomy (operation to remove her gall bladder) between September and October 2023.

5. She specifically complains that the Trust:

• did not prioritise her or treat her with more urgency based on her symptoms on 18 September 2023 or expedite her surgery at this point

• did not remove her gallbladder during her admission for acute cholecystitis between 20 - 23 October 2023

• discharged her on 23 October and 30 October 2023 when she was not well enough

6. Miss R says that when she was discharged and despite attending the Trust again she:

• continued to experience extreme abdominal pain • became housebound due to pain • was unable to work • could only eat soup and lost two stone in weight • was terrified she would develop sepsis.

7. Miss R says as a result of these issues she felt she had no choice but to pay to have the operation privately, which was done on 23 November, and it cost her £7000.

8. Miss R says she wants the Trust to acknowledge any failings, apologise to her, pay her a financial remedy and make improvements to services.

9. In September 2023, Miss R was placed on the waiting list for an elective laparoscopic cholecystectomy (an operation to remove her gallbladder) due to ongoing issues with gallstones.

10. From 20 to 23 October 2023, Miss R was admitted to the Trust with acute cholecystitis (inflammation of the gallbladder), she received intravenous antibiotics and pain relief and was discharged.

11. On 30 October 2023, Miss R’s GP referred her back to the Trust as she continued to experience significant pain. Although staff informed her that she had been moved up the priority list for her operation, they also indicated it could still take a further three to six months for the surgery to take place.

12. Feeling she had no alternative, Miss R chose to pay for private surgery to remove her gallbladder, which took place on 23 November 2023 at a personal cost of £7,000.

16. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation got something wrong. We do this by comparing what should have happened with what did happen.

17. We have done this and have found no indication that the Trust did anything wrong.

Urgency of treatment in September 2023

18. Miss R says she should have been prioritised or treated with more urgency in September due to the pain she was in, and the symptoms she was experiencing.

19. The Trust confirmed in its response dated 15 January 2024 that Miss R was seen on the 7 July 2023 in the Same Day Emergency Care by a registrar for biliary colic symptoms (sudden, intense pain caused by a temporary blockage in the bile ducts, usually due to gallstones) and staff requested an ultrasound scan.

20. Records show an ultrasound scan was done on the 27 July 2023 and the results showed a thin wall gallbladder, with no signs of inflammation present, and there were no significant changes in her blood test results.

21. The Trust also said Miss R was seen in clinic on the 18 September 2023 when she was added to the waiting list initially on code P3 (the Trust use priority coding - priority 2 (P2), priority 3 (P3) and priority 4 (P4). P2 is the most urgent code). The Trust explained Miss R developed acute cholecystitis on the 19 October 2023 and was treated conservatively and was expedited to P2 coding due to her symptoms.

22. The consultant’s secretary offered Miss R an operation date for 23 January 2024. Miss R advised the secretary that she had decided to be treated privately, and the operation was due to take place on 23 November 2023, so Miss R was then removed from the waiting list.

23. We have considered NICE Clinical Guideline on Gallstone Disease (CG188) which provides recommendations for the diagnosis and management of gallstone disease in adults. This guideline focuses on identifying, assessing, and treating gallstones and their complications, and the prioritisation of any surgeries required.

24. It explains that patients with biliary colic (pain caused by gallstones) where there are no signs of inflammation or infection on imaging or blood tests, should be managed with a planned (elective) laparoscopic cholecystitis. It explains the level of urgency is determined by the presence of complications, rather than the severity of pain in isolation.

25. Our adviser says there is no clinical evidence from the medical records that Miss R should have been expedited in September. The adviser says the records show there was no evidence Miss R had inflammation around the gallbladder, and she did not have any significant changes in her blood tests, and she had no signs of sepsis or infection.

26. Our adviser said there was no clinical reason for Miss R to be prioritised over other patients.

27. From Miss R’s account we understand she was in a lot of pain in September when she attended her appointment at the Trust. Given she later developed acute cholecystitis we can appreciate why she thinks the Trust should have taken more urgent action at that time.

28. Based on the evidence we have seen, we cannot say the Trust should have prioritised or treated her case as more urgent. This is because based on the tests the Trust carried out at the time, there was no indication of infection or inflammation which would have suggested a need to prioritise her treatment under NICE guidance.

29. We are very sorry to hear of Miss R’s condition and appreciate how distressing it must have been for her. Based on the evidence and in accordance with the relevant guidance, we are satisfied the Trust acted within the expected standard of care at the appointment in September.

Treatment of acute Cholecystitis in October 2023

30. Miss R says when she was admitted on 20 October with acute cholecystitis (inflammation of the gallbladder) the Trust treated her with antibiotics and did not consider removing her gallbladder at this point or move her further up the priority list.

31. She says the Trust did not act in line with the relevant clinical guidelines when it did not perform the surgery to remove her gallbladder during this admittance.

32. The Trust said that on the 20 October Miss R developed acute cholecystitis and she was treated conservatively. It said due to Miss R’s significant symptoms she was expedited to code P2 which increased her priority for surgery. The Trust says P2 code is normally used for cancer patients.

33. The Trust said at this point Miss R was not suitable for an emergency cholecystectomy due to higher risks of complications. It said she was treated with antibiotics and her inflammatory markers improved.

34. The Trust also said that a period of two to three months is needed for the inflammation to settle to ensure safer surgery.

35. GMC ‘Good Medical Practice’ (2013) explains clinicians have a duty to ‘adequately assess’ a patient’s condition.

36. We have also considered Tokyo Guidelines 2018: initial management of acute cholecystitis.

37. This states in Figure 8 – 10, once the diagnosis has been confirmed, initial medical treatment should be started immediately, the severity should be assessed according to the severity grading criteria for acute cholangitis/cholecystitis, and the patient's general status should be evaluated.

38. The guidance says for Grade I (mild) cases of acute cholecystitis, treatment should start with antibiotics and general supportive care, followed by either close monitoring or scheduling keyhole surgery to remove the gallbladder (called laparoscopic cholecystectomy) shortly after the diagnosis.

39. The guidance says for Grade II (moderate) the patient should be given antibiotics and general supportive care then either an urgent/early laparoscopic cholecystectomy, delayed elective laparoscopic cholecystectomy, or urgent/early gall bladder drainage.

40. For Grade III (severe) cases, the guidance advises to start antibiotics immediately. If possible, staff should take a blood culture before giving antibiotics but should not delay treatment. The guidance advises staff to look for serious warning signs, such as yellowing of the skin or eyes (jaundice), confusion, or breathing problems. They should assess whether any organ failure is limited to the heart or kidneys and likely to improve with proper care. They should evaluate the patient’s risk for surgery by considering their age, chronic health conditions, overall health, and ability to tolerate.

41. Overall, the guidelines above make clear that the treatment for acute cholecystitis needs to be based on the patient's overall condition, with clinical judgement determining whether surgery is appropriate at the time.

42. While it says that an early cholecystectomy can be appropriate in some circumstances, it also says that initial conservative management including antibiotics and supportive care, followed by delayed cholecystectomy undertaken when the patient's condition has improved can often be more appropriate and carry less risk.

43. We also considered the Swedish Register Timing of Elective Cholecystectomy After Acute Cholecystitis guidance. The guidance says the best time to perform a cholecystectomy for patients with acute cholecystitis is within the first two days of admission.

44. However, it also notes that surgeries done on the first day may have slightly higher risks, so it is important to stabilise the patient’s condition beforehand.

45. The records show at this admission, Miss R did have cholecystitis, inflammation of the gallbladder. We have discussed this with our adviser.

46. They have explained that while the guidance above identifies that an early cholecystectomy is often the preferred treatment, it is not mandatory or appropriate in all cases.

47. They explained that the guidance allows for clinical judgement, which may mean that immediate surgery is not appropriate and that often, initial management with antibiotics is a recognised approach and reflects standard clinical practice and is in line with the guidance above.

48. In addition, they explained that managing the condition with antibiotics, followed by planned, delayed surgery (rather than immediate), is supported by the guidance above. This is because delaying the cholecystectomy until any inflammation has settled can make the surgery safer and more appropriate.

49. At the time of this episode, the Trust reviewed Miss R’s position on the waiting list for gallbladder removal and appropriately escalated her to priority level P2, meaning she would have had her operation sooner than prior to this admission.

50. Therefore, in line with the evidence we have seen we consider the Trust acted within established GMC and clinical guidance which supports delaying cholecystectomy until inflammation has settled, treating Miss R initially with antibiotics, and with a planned interval between the acute episode experienced here and elective surgery.

51. Overall, we are satisfied the Trust’s approach was consistent with accepted clinical standards and that it provided care in line with good clinical practice. This approach balances the need to manage Miss R’s acute symptoms safely while planning surgery at the most appropriate and clinically effective time.

52. GMC’s Decision making and consent guidance (2020) says that clinicians should share the relevant information about the benefits and harms of proposed options and actively explain the risks and benefits. We can see from Miss R’s records that in line with this guidance the Trust explained its treatment rationale, that because there was lots of inflammation, it would not be appropriate to do surgery at that point as there was higher risks of complications, but that it would expedite her surgery.

53. For the reasons above we did not find any failings in relation to the Trust’s action during this admission.

Surgery wait times

54. Miss R tells us that although the Trust moved her up the priority list for her operation after her admittance, the Trust told her it could be a further three to 6 months before she would likely have her operation.

55. The Trust says the consultants do not manage or have any direct influence over their waiting lists. Patients are added to waiting lists and they are operated on according to priority coding.

56. It said that when Miss R was treated for Acute Cholecystitis in October, and her priority was expedited she was given an operation date for January.

57. We considered this timescale alongside the clinical advice we received.

58. Our adviser explains that typical waiting times for elective cholecystectomy can be significantly longer, noting average waits of around 12 to 15 months. In this context, Miss R was offered surgery sooner than would ordinarily be expected.

56. We are sorry to hear that Miss R found the wait distressing given the pain she was experiencing.

59. However, taking into account the clinical advice, the relevant guidance on managing acute cholecystitis, and the evidence of how waiting lists are prioritised, we consider that the Trust acted in line with the PHSO’s Principle of Good administration in that it prioritised Miss R based on clinical need and managed her care based on this as well. We have seen no indication that the timescale in this case reflects a failing by the Trust.

Discharge 23 October and 30 October

60. Miss R says the Trust discharged her on 23 October 2023 and also on the 30 October when her GP had referred her back to the Trust, she says she was not well enough to be discharged, and she was in considerable pain.

61. GMC ‘Good Medical Practice’ (2013) explains clinicians have a duty to ‘adequately assess’ a patient’s condition and ‘formally record’ any clinical findings in a ‘clear, accurate and legible’ way.

62. National Early Warning Score (NEWS) is used to monitor and assess how stable a patient’s condition is. It measures:

• Respiratory rate – Breathing rate.

• Oxygen saturation – How much oxygen is in the blood.

• Systolic blood pressure – The pressure in blood vessels when the heart beats.

• Pulse rate – Heart rate.

• Level of consciousness – Whether the patient is alert, responsive to voice or pain, or unresponsive (AVPU scale).

• Temperature – Body temperature.

63. Our adviser says, having reviewed Miss R's NEWS scores prior to her discharges, her observations were stable, and clinicians deemed her clinically safe for discharge. They noted that although her blood test levels remained raised, she was sent home with antibiotics to address this. Her pain, while present, was managed effectively with analgesia that could be administered at home in tablet form.

64. Our adviser says if Miss R had not felt well enough to be discharged, she could have communicated this to staff, but there is no record of her raising any concerns at the time.

65. Our adviser says on both occasions, on clinical criteria alone, Miss R was fit enough to be discharged.

66. We are sorry to hear of the experiences that Miss R has gone through. We see no evidence of any potential failings in her discharges so we will not be looking at this any further.

Conclusion

67. We would like to take this opportunity to thank Miss R for bringing her complaint to us. We appreciate the difficulties and distress she has faced, and we do not take lightly the experiences she has endured.

68. We hope we have clearly explained the reasons why we will not be taking further action. We would like to wish Miss R the best for the future.

1. We have carefully considered Miss R’s complaint about the Trust. We are sorry to hear of the level of pain and discomfort Miss R has experienced and recognise that this was an extremely difficult time for her.

2. Having carefully considered Miss R’s complaint, we have decided not to investigate it further. This is because the Trust followed the relevant guidance it should have done when treating her symptoms.

3. We are sorry if our decision causes any further distress, as this is not our intention. We thank Miss R for bringing this complaint to us. We hope this statement explains our decision clearly.