Discharge without antibiotics or appropriate advice on 19 May 2023
17. The Trust’s operation notes show Mrs L was discharged home the same day following her gallbladder surgery and she was not given antibiotics to take home.
18. Mrs L said staff told her the surgeon removed her gallbladder with a bag as it was infected. It is noted in Mrs L’s operation notes staff used an Endobag to extract Mrs L’s gallbladder. An Endobag (also known as an endoscopic specimen retrieval bag) is a single-use specimen bag used in laparoscopic (keyhole) surgery, which is the type of surgery Mrs L had. The bag is used to retrieve tissue from the abdominal cavity, such as the gallbladder.
19. Our clinical adviser said there is no evidence from the operation note Mrs L’s surgery was complicated, nor was she at a higher risk of wound infection.
20. In the complaint response, the Trust said Mrs L’s operation was uneventful. The surgeon noted Mrs L’s gallbladder was inflamed during the operation. The Trust response said the risk of infection is higher if the gallbladder is inflamed.
21. Our clinical adviser said gallbladder inflammation does not necessarily mean it was infected.
22. The Trust told us it does not routinely prescribe antibiotics prophylactically (to prevent infection occurring) for gallbladder surgery. The Trust told us the only exception is if the gallbladder is cut during the surgery and this leads to spillage of bile (a digestive fluid stored in the gallbladder). The Trust told us no mention of bile spillage was documented in Mrs L’s operation note from 19 May 2023. The Trust apologised if it did not make it clear to Mrs L at the time its standard practice is to not give antibiotics without medical justification.
23. Our clinical adviser said there is no national guidance on routine antibiotic use for patients undergoing planned surgery for gallbladder disease. However, they said Surgical Infection Society guidelines show most research suggests these patients do not need antibiotics routinely.
24. This is because most of these patients do not benefit from antibiotics and antibiotics may have side effects. Our clinical adviser told us a national audit of antibiotic prophylaxis in 2015 found 64% of surgeons do not routinely give antibiotics for the type of surgery Mrs L had.
25. GMC Good Medical Practice says medications must only be prescribed when the doctor is satisfied it will meet the patient’s needs. It also says prescription of medications must be based on the best available evidence.
26. We acknowledge Mrs L said staff told her gallbladder was infected. We have not found any indication in Mrs L’s medical records that her gallbladder was infected, or that staff informed her of this. We cannot make an evidence-based decision on this conversation because it is not documented.
27. Having carefully considered the evidence available, we have found the Trust acted in line with national guidance and followed evidence by not prescribing Mrs L with antibiotics when she was discharged. This is because there is no requirement for routine prescribing of antibiotics following gallbladder surgery.
28. Mrs L told us she would have attended A&E sooner when she experienced pain and swelling after her operation, had the Trust given her proper advice.
29. We have reviewed Mrs L’s relevant medical records. In Mrs L’s discharge summary following the operation, it is documented staff told Mrs L to seek medical advice if she felt unwell or experienced swelling at the site of her operation. Our clinical adviser told us these symptoms could indicate an infection. They said this was appropriate discharge advice and Mrs L followed this advice when she attended A&E on 27 May 2023, with increased pain, fever and bleeding from her navel (tummy button).
30. It is documented in Mrs L’s medical records staff gave her an information leaflet about gallbladder surgery at a clinic appointment two months before her operation took place. The Trust provided us with a copy of this leaflet. Mrs L says she never received it.
31. The information leaflet contains a section on what complications can happen. The list of complications includes infection of the surgical site (wound) and developing a hernia (tissue pushing through a weak area in the abdominal wall) near one of the cuts.
32. GMC Good Medical Practice says if you assess, diagnose or treat patients you must promptly provide or arrange suitable advice, investigations or treatment where necessary.
33. Mrs L told us she was not given advice when she was discharged home after her gallbladder surgery. She said a nurse shouted down the corridor she could go home, and to contact the hospital or her GP if she had any problems.
34. We can see a difference of opinion between Mrs L and the Trust over what information Mrs L received. The Trust said it gave Mrs L an information leaflet which included information about common complications and what to do if you become unwell after surgery. Mrs L said she did not receive this. We can see that when the Trust discharged Mrs L it gave her a discharge summary which said to seek medical attention if she felt unwell or saw swelling at her operation site. We also know the Trust told her to contact the hospital or her GP if she had any problems.
35. We are satisfied that even if the Trust did not give Mrs L a leaflet about the surgery, it still gave Mrs L adequate advice on discharge about what to do if she had any problems. This was in line with GMC Good Medical Practice. As the Trust’s actions were in line with relevant standards, we are not upholding this part of Mrs L’s complaint.
36. We are sorry this is not the outcome Mrs L was hoping for. We are reassured Mrs L knew to seek medical advice when she became unwell and hope our explanation brings closure to Mrs L on this issue.
Failure to properly communicate the risks of complications from gallbladder surgery
37. Mrs L complains the Trust failed to properly communicate the risks of complications from gallbladder surgery. She said surgeons told her the risk of a complication from her operation was 0.1%. Accordingly, she had the expectation a complication would not happen.
38. In its response to Mrs L’s complaint, the Trust said around 5% of patients may experience a wound infection after their operation. The Trust also said the risk of developing a port-site hernia (when tissue around the surgical incision does not close properly, and contents of the abdomen protrudes through the gap) varies between 0.5% and 5% depending on which literature you read.
39. Our clinical adviser told us there is no national consensus on the level of risk of gallbladder surgery. They told us about a national study of outcomes following gallbladder surgery, which suggests the overall risk of complications is around 10%. They also highlighted a national review of consent forms for gallbladder surgery, which suggests the risk of complications from gallbladder surgery is inconsistent.
40. GMC Good Medical Practice says doctors must give patients the information they want or need to know in a way they can understand. It also says doctors must share with patients the information they need to make decisions about their care, including treatment options and the associated risks.
41. Mrs L’s medical records say a surgeon discussed gallbladder surgery and the associated risks with her during a clinic appointment on 13 March 2023. It is also documented the Trust gave Mrs L an information leaflet about gallbladder surgery at this appointment.
42. We have reviewed the information leaflet provided by the Trust. The information leaflet lists general complications that can happen following any operation including wound infections, and complications specific to keyhole surgery (which is the type of surgery Mrs L had) including developing a hernia near one of the cuts.
43. Mrs L told us she was not given an information leaflet.
44. Mrs L’s medical records also contain the operation consent form which she signed prior to surgery. The consent form lists risks which are significant, unavoidable or frequently occurring. This list includes infection.
45. Mrs L said she had never seen her surgeon before the day of her operation. She told us she only saw him for five minutes before her operation to complete the consent form. She said she had to sign the consent form, or her operation would not have gone ahead.
46. Our clinical adviser said the GMC guidance on consent advises doctors to be proportionate and give patients the information they need to make a decision, including any information of particular importance to them.
47. We are unable to reach a decision on whether staff gave Mrs L an information leaflet. We recognise Mrs L’s account the Trust told her the risk from gallbladder surgery was 0.1% and so she had the expectation she would not experience a complication. We have not seen this figure documented anywhere in her records. We can see staff discussed risks of surgery with Mrs L in a clinic appointment. The surgeon also went through the consent form with Mrs L albeit briefly, which highlights risks, and she signed his.
48. We have found that even if the Trust did not give Mrs L the information leaflet, the Trust gave Mrs L appropriate information about the risks of gallbladder surgery in the discussion two months before the operation and when she signed the consent form on the day of surgery.
49. We are very sorry Mrs L experienced complications following her gallbladder surgery and to learn of the impact this had on her. We understand her complications have been ongoing and appreciate this has been a very difficult time.
50. We hope we have clearly explained why we have not identified any failings in the Trust’s actions. We believe the Trust acted in line with national guidance by providing Mrs L with information which included the risk of complications from gallbladder surgery. We therefore do not uphold this part of Mrs L’s complaint.
Surgical procedure without pain relief
51. Mrs L complains the Trust carried out a surgical procedure without giving her appropriate pain relief. Mrs L went back to hospital with a wound infection on 27 May 2023, following her gallbladder surgery. In her complaint, Mrs L says she was in horrendous pain and could not tolerate anyone touching her stomach. We are sorry Mrs L had such a painful and distressing time.
52. A surgeon reviewed Mrs L and documented at 11.44am she was in visible distress due to pain. Mrs L’s medication chart shows staff gave her paracetamol at 11.34am and 4.47pm. It is also documented staff did not give Mrs L dihydrocodeine (stronger pain relief prescribed for moderate to severe pain) at 3.19pm as she was not in pain.
53. Mrs L said she never declined pain relief. We recognise her account differs from what staff documented in the clinical records.
54. The nursing records say Mrs L’s pain score at rest and on movement was five at 1.07pm. Her pain score at rest and on movement was documented as zero at 2.13pm and 6.31pm. The Trust explained pain scores are used to objectify a subjective symptom such as pain. Staff ask the patient to tell them their pain on a scale of zero to ten, with zero being no pain and ten the worst pain they have ever felt. The scores are mainly used to assess a patient’s progress.
55. The records say a doctor removed the stitches from Mrs L’s wound at around 5pm. The doctor has documented pus came out and they cleaned the wound cavity with a small swab. The doctor left a further swab inside the wound to absorb any more pus and covered the wound with a new dressing. Mrs L said this procedure was carried out without pain relief and in her complaint to the Trust, said she was in so much pain, she nearly broke her partner’s arm. We recognise this was a very painful and distressing procedure.
56. In its complaint response, the Trust apologised Mrs L experienced so much pain during the procedure. It said due to the pain Mrs L was experiencing, the doctor covered Mrs L’s wound with a dressing, to return the following day to clean the wound under local anaesthetic. It is documented in the medical notes the next day, a surgeon gave Mrs L local anaesthetic then further cleaned and packed her wound.
57. In its letter after the first local resolution meeting with Mrs L, the Trust said staff routinely remove stitches without pain relief. The Trust also said staff should have considered Mrs L’s pain threshold and offered appropriate pain relief.
58. It its letter after the second local resolution meeting with Mrs L, the Trust explained the standard procedure for an infected surgical wound is to open up the wound, which normally involves cutting the stitches. This allows the infection to come out. The Trust said it was its responsibility to ensure staff know the pain threshold of their patients. It also said staff should not continue with a procedure clearly causing pain. The Trust acknowledged it failed to assess and manage Mrs L’s pain before starting the procedure.
59. Our clinical adviser said pain is subjective and variable between individuals. They said it is not normal practice to give anaesthetic or pain relief before removing stitches. They also said because Mrs L’s wound was infected, it would have been tender, more painful and less pleasant for her.
60. GMC Good Medical Practice says doctors must provide a good standard of care, and when treating patients, must provide treatment promptly. Our clinical adviser said Mrs L had regular pain relief in the day and her pain score had been documented as zero (no pain) that afternoon. They said it was therefore reasonable for the Trust to try and carry out this procedure without anaesthetic initially. They said if it had been successful, Mrs L would have been able to go home that day.
61. Our clinical adviser noted Mrs L was sensitive to the pain of the procedure. They said Trust staff took Mrs L’s pain into account, stopped the procedure and reattempted this with local anaesthetic the following day.
62. GMC Good Medical Practice says doctors must take all possible steps to alleviate pain and distress. Our clinical adviser said this is an underlying principle of the medical profession, but it is not always possible to avoid pain completely. Some procedures are essential but do cause pain.
63. We are mindful the Trust said it should have assessed Mrs L’s pain prior to removing her stitches on 27 May. We acknowledge Mrs L’s account of the pain she was in. Mrs L said she was in pain from the time she was admitted to hospital. She disagrees her pain score was zero and said she never told staff she was not in pain. We understand this was a very distressing experience.
64. We also acknowledge the Trust’s account of what happened and what our clinical adviser and national guidance says should have happened.
65. Trust staff gave Mrs L pain relief during the day of 27 May 2023. The Trust followed its standard procedure by removing Mrs L’s stitches to open her wound and allow the infection to come out. The Trust and our clinical adviser told us local anaesthetic is not normally given to remove stitches.
66. Having carefully considered all the evidence, we found it was in line with standards for staff to initially attempt this procedure without anaesthetic. We can see staff did consider Mrs L’s pain and stopped the procedure when she was in pain. This was in line with GMC Good Medical Practice guidance to take all possible steps to alleviate pain and distress.
67. We have not identified any failings in the Trust’s actions, and do not uphold this part of Mrs L’s complaint.
68. We know Mrs L has had a difficult recovery from gallbladder surgery due to the unexpected complications she suffered. We appreciate her distress and that she was in significant pain and are sorry she has gone through this.
69. We thank Mrs L for bringing her complaint to us. We hope she is reassured we have not found any evidence the Trust did anything wrong and this decision can bring her some closure.