Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

3. Mr A complains about care provided to his wife, Mrs B, by Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust (the Trust) from 21 to 23 March 2024 after she went to hospital for a procedure to remove her gallbladder. Specifically:

• Mr A says his wife’s procedure was unnecessary as her gallstones were not troubling her. Therefore, the procedure should not have taken place • When a fragile and unusual looking artery was discovered during the procedure, why was a reef or square knot not used which may have prevented post-operative bleeding.

4. Mr A says his wife died unexpectedly on 23 March 2024, two days after what should have been a routine procedure to remove her gallbladder. Mrs B had been discharged after her procedure on 21 March 2024 but had to return to hospital the following day. She had an active bleed at the gallbladder site. Mrs B was treated for her bleed and in the Intensive Care Unit but sadly died. Mr A had been with his wife for 46 years and has been greatly impacted by her death which he feels could have been avoided.

5. As an outcome, Mr A wants a financial remedy from the Trust.

6. Please note that we have not included all the background to the complaint in this report as all parties already know this information. We have included the information outlined in this section to put the complaint into context.

7. Mrs B was 75 years old. She had a history of hypertension, angina, acid reflux, chronic kidney disease, and dementia. Mrs B also had a clinical background of gallstones and although she was asymptomatic, the Trust had recommended that she have her gallbladder removed to eliminate the chance of future serious complications such as inflammation, infection, jaundice, and pain.

8. Mrs B had a cholecystectomy on 21 March 2024. During the surgery, an unusual looking artery or blood vessel was discovered, but it did not affect the completion of the surgery. Mrs B’s post-operative observations including her blood pressure were within normal parameters. There was no sign of bleeding at the end of surgery or signs of any significant bleed to come, so she was discharged home as planned.

9. Unfortunately, Mrs B had to return to hospital the following day after becoming unwell due to vomiting. A CT scan discovered an active bleed at the gallbladder site. Mrs B was taken back to theatre and the surgeon found that the bleed was occurring from where the unusual looking artery or blood vessel had been seen during her original surgery. The bleed was controlled and repaired by the surgeon and Mrs B’s abdominal cavity was cleared. Mrs B was monitored in the Intensive Care Unit (ICU), but she developed multi-organ failure.

10. Sadly, Mrs B died on 23 March 2024. The cause of her death was Multi-organ failure, Cholecystectomy with complication, Ischaemic heart disease, Hypertension and Bronchopneumonia.

Unnecessary procedure

15. Mr A says his wife’s procedure was unnecessary as her gallstones were not troubling her at the time. Therefore, the procedure should not have taken place.

16. We note from the records that the Trust had advised Mrs B to have her gallbladder removed to eliminate the chance of future serious complications, as outlined in the background section of this report, even though she was asymptomatic at the time of her surgery. Mrs B signed a consent form for her cholecystectomy on 21 March 2024.

17. Having considered the relevant records, our adviser says Mrs B had clinical circumstances which meant that some intervention was necessary by the Trust. In 2023, Mrs B had stones that had moved out of her gallbladder and were sat in her common bile duct. She had presented with biliary colic. This had required an Endoscopic Retrograde Cholangiopancreatography (ERCP). This is a procedure combining upper GI endoscopy and x-ray to diagnose and treat bile/pancreatic duct issues like stones, tumours, or strictures.

18. Mrs B had also had a sphincterotomy which is an endoscopic procedure undertaken to open the valve at the lower end of the bile duct. Our adviser says the purpose of this was to allow stones and sludge within her bile duct to drain more easily. The cut that is made in the lower end of the bile duct is considered to be a permanent change in the drainage of the bile duct. In patients who are very elderly or who have significant comorbidity making surgery undesirable, it is often used as a definitive procedure.

19. Our adviser has added that while a sphincterotomy cannot guarantee improvement of all biliary pain and symptoms, it prevents the important risks of obstructive jaundice or acute pancreatitis developing from a stone passing out of the gall bladder and becoming impacted at the lower end of the bile duct.

20. As for whether Mrs B’s cholecystectomy should have gone ahead, our adviser says this decision was a balance between the risk of surgery, Mrs B’s symptoms, and her comorbidity. Gallstones can recur, particularly if the gallbladder is not removed. While this eliminates the primary source of the stones, new stones can still form in the bile ducts. The Trust’s explanation was that Mrs B’s gallstones could potentially cause symptoms even though she had no symptoms at the time of her surgery.

21. While this is certainly true, our adviser says the risk of further symptoms was lower for Mrs B because she had undergone ERCP and sphincterotomy. She might have experienced further gallbladder pain and sphincterotomy would not have reduced this risk. The records indicate that Mrs B had been diagnosed with dementia, but it is unclear how severe her condition was. Our adviser says that if Mrs B was disabled by her dementia, then surgery on the balance of probabilities would have been inadvisable. If Mrs B’s dementia was not that severe, then the decision to advise surgery by the Trust was more reasonable.

22. In the absence of additional information in the records about the severity of Mrs B’s dementia, we asked Mr A for some further information about his wife’s condition. Mr A described his wife having memory issues and experiencing forgetfulness. She was slower and needed support with some tasks. Mrs B also tended to repeat herself at times. In summary, the picture painted by Mr A is that his wife had mixed type dementia.

23. Nevertheless, Mr A acknowledges that his wife’s symptoms improved after she was prescribed medication for her dementia. As we have said, there is evidence in the records that Mrs B signed the consent form for her cholecystectomy on the day of the surgery. The Trust says in its complaint response that Mrs B was seen by the surgeon before her procedure. The risks of the procedure were explained, and she was deemed fit for surgery.

24. Overall, we appreciate and acknowledge Mr A’s account of the extent of his wife’s dementia, as well as the information provided by the Trust. We have not seen any evidence in the records documenting specific concerns about Mrs B’s dementia affecting her ability to consent to the cholecystectomy, or any specific concerns about her fitness to have this surgery. The records reflect that Mrs B was fit enough to have the cholecystectomy and she consented to the procedure. Mrs B had a history of gallstones migrating from her gallbladder to her bile duct. Having cholecystectomy, in accordance with the NICE guidance, reduces the risk of stones recurring and the patient experiencing related health issues. The records indicate that Mrs B’s cholecystectomy was an appropriate course of action in the circumstances.

25. As for the surgery itself, our adviser says the operation note indicates that Mrs B’s surgery was carried out following the steps normally expected for laparoscopic cholecystectomy in keeping with standard practice. There were no concerns at the time her operation note was written and the surgery was straightforward.

26. There is no mention in the operation note of the artery looking peculiar or the anatomy or appearance of the artery being unusual. There is no description of any consideration being given to securing the artery other than applying metal clips. Mrs B was returned to the recovery area and on the ward her post-operative observations were stable. Our adviser says Mrs B met the criteria for discharge from hospital and was sent home at around 10pm on 21 March 2024 after being given Dalteparin. This is an anticoagulant/blood thinner medication commonly used after surgery to prevent conditions such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). The Trust said in its complaint response that there was no bleeding at the end of Mrs B’s original surgery.

Fragile and unusual looking artery

27. Mr A says when a fragile and unusual looking artery was discovered during the procedure, why was a reef or square knot not used which may have prevented post-operative bleeding.

28. Firstly, our adviser says the description of a fragile and unusual looking artery is puzzling. It raises the question of why if it was considered so unusual did the surgeon not get another opinion on it and how best to secure it. As above, there is no mention of a fragile or unusual artery in the primary operation note of the laparoscopic cholecystectomy.

29. From their experience of clinical practice, our adviser says that surgeons often describe unusual anatomy but usually this is because of a loss of situational awareness. That is, they are operating in the wrong place or have misinterpreted the anatomy. The “fragile” description of the artery may have arisen because it was over dissected removing the serosal coat (tough outer coat) of the artery making it partly transparent as described. The use of metal clips to control arteries is common practice in the UK. The problem with applying a metal clip to a denuded artery is that it has the potential to cut through the soft muscular and intimal (inner lining) of the artery.

30. As for whether a reef or square knot might have prevented the post-operative bleeding that Mrs B suffered, our adviser says this is difficult to say with confidence. Intracorporeal knot tying (tying a knot inside the body using long laparoscopic instruments) is a technically difficult feat and we do not know if the treating surgeon had been trained to do this.

31. There is a commonly available device in operating theatres called an Endoloop or similar. This device provides a pre-knotted ligature on a pusher which makes knot tying simple and safe with an excellent success rate. The operation note for Mrs B’s surgery does not mention whether it was considered to use this device to secure the artery. On the balance of probabilities, our adviser says it is likely that securing the artery with an Endoloop or ligature would have reduced the likelihood of bleeding. The other alternative was to use Hemolok clips (locking plastic clips). These clips were used during Mrs B’s surgery to secure her cystic duct during the process of gall bladder removal and so they were available at the time of her surgery.

32. We consider this is a failing by the Trust as, on the balance of probabilities, securing Mrs B’s artery with an Endoloop, ligature or Hemolok plastic clip would have reduced the likelihood of her suffering the post-operative bleeding that occurred. We consider this causes Mr A uncertainty about some of the care provided to his wife which is distressing for him. Therefore, we have made recommendations about this.

33. To address her post-operative bleeding, Mrs B had to return to hospital on 22 March 2024. Our adviser says Mrs B was suffering from hypovolaemic shock and therefore, it would have been a difficult situation to operate under these circumstances. The surgeon undertook a midline laparotomy (open operation in the abdomen). It was established that Mrs B had extensive bleeding and clots. These were removed and packs placed to temporarily control the bleeding so that the anaesthetists could administer fluids to Mrs B to restore her circulation.

34. When Mrs B was more stable, the surgeon identified the bleeding point and controlled it. A drain was placed in Mrs B’s abdomen and the surgeon washed out any remaining blood before closing. Our adviser says the Trust’s management of this repair procedure was appropriate and gave Mrs B the best chance of recovery.

35. Mrs B was returned to the intensive care unit. Our adviser says Mrs B had pre-existing chronic kidney disease and in the face of a major haemorrhage her kidneys went into acute on chronic kidney failure. Because of this, Mrs B was difficult to support and ventilate on the intensive care unit. Unfortunately, Mrs B developed progressive multiple organ failure despite maximal support, and a decision was made to palliate her. Mrs B sadly died on 23 March 2024. There is no evidence from the information we have considered that this tragic event could have been avoided.

1. We have seen a failing by the Trust regarding its management of Mrs B during her cholecystectomy on 21 March 2024. On the balance of probabilities, different techniques in terms of securing Mrs B’s artery should have been considered that would have reduced the likelihood of her suffering the post-operative bleeding that occurred. We consider this causes Mr A uncertainty about some of the care provided to his wife which is distressing for him. We have not seen any other failings regarding the care provided to Mrs B by the Trust.

2. Therefore, we will partly uphold Mr A’s complaint about the Trust. These are our recommendations:

• the Trust should acknowledge its failing in Mrs B’s management, as summarised in paragraph 32 and apologise to Mr A for the uncertainty and distress this causes him about his wife’s care • the Trust should develop an action plan to address the failing summarised in paragraph 32. It should identify any specific reasons for this failing and the learning it has taken from these issues. It should explain what it will do differently in future, who is responsible and timescales for each action, as well as how these will be monitored • the Trust should pay Mr A £200 as a personal remedy in view of the uncertainty and distress caused to him by the failing in his wife’s care.