14. Miss I says staff did not inform her, prior to her operation for a rectocele prolapse in August, that her surgery could result in her having a colostomy bag fitted. She explained that she developed a fistula between her vagina and back passage following her operation, resulting in her needing a colostomy bag. She accepts she gave consent but says this was uninformed.
15. Miss I explained that there was no clinical need for the procedure, it was just to alleviate her discomfort. She says categorically that if she had known there was even a slight risk of this, she would never have agreed to go ahead with the procedure.
16. Miss I further explained that she has endometriosis and has been having treatment from the Trust since around 1994. She explained that she has always had a fear of needing a colostomy bag. During the consent process for all of her other gynaecology procedures, she said she had been verbally advised of the risk of this and was able to weigh up the benefits and risks at the time.
17. The Trust accept there was no record of colostomy being specifically discussed with Miss I but said risk to the bowel is mentioned. However, they said they would not have expressly mentioned it during the consent process as this is so rare a complication. The surgeon explained that had Miss I asked a specific question about a colostomy at the time, they would have advised that in their experience it had never happened.
18. We sought some advice from a consultant gynaecologist who directed us to The Royal College of Obstetricians and Gynaecologists (RCOG) guidance about carrying out consent for prolapse surgery (Consent Advice No. 5), to understand what should have happened.
19. The guidance confirms that it is important to mention the possibility of bowel injury occurring during the surgery. However, the guidance does not specifically mention a risk of colostomy formation.
20. The consent form does include mention of damage to the bladder, bowel, and any extra procedures that may become necessary at the time of the procedure but does not go into more detail about this or mention the word ‘colostomy’. The consent form says serious or frequently occurring risks include pain, bleeding, infection, damage to bowel/blood vessels/bladder, voiding difficulties, and recurrence. We can see that Miss I signed this on 2 June.
21. The consent form clearly indicates the possibility of damage to the bowel. It has been signed, suggesting Miss I saw this. She does not dispute this. However, in line with the RCOG guidance above, there was no specific requirement to discuss the possibility of a colostomy bag. As such, while we appreciate Miss I is clear she did not have all the information available to her, that she required during the consent process, we cannot say there is a failing on the Trust’s part in this.
22. Our adviser went on to explain the lack of reference is likely because most cases of bowel injury occurring during such surgery are recognised at the time of the operation and will usually be repaired without the requirement for colostomy. The adviser explained that in this case it was the delay in the fistula appearing which resulted in the need to defunction the bowel, by performing colostomy.
23. The still current RCOG consent guidance on prolapse does not mention colostomy, and our adviser explained that it is a very unusual requirement following such a procedure. Given Miss I expressed that she had a specific fear of needing a colostomy bag, if she had raised this with the surgeon, we would have expected them to discuss this in more detail with her. However, we have seen nothing to suggest she raised this with staff and given there was no requirement for staff to specifically discuss this with Miss I, their actions were therefore in line with the guidance. We found no failing here.
Mistake during surgery
24. Miss I says that she believes staff made a mistake during her rectocele prolapse surgery, on 10 August, leading to her needing a colostomy bag. She says she did not have a fistula prior to her surgery, so argues that this could only have resulted from her operation.
25. She says that when she complained, a member of staff at the Trust told her that a clinician had reported this already on the system and she says this rang alarm bells for her. She queried why a clinician would flag this up if it was a known complication.
26. Miss I explained that she only realised she had a problem when diarrhoea started to come from her vagina as well as her back passage. She believes that this happened during the procedure, but that it was only once she had diarrhoea that it became apparent. She explained that she does not empty her bowels frequently, and suffers badly with constipation, so every couple of weeks she takes laxatives to help her. She therefore disputes that she would have noticed this sooner.
27. The Trust says the operation was straightforward, without any problems, with only a 1% incidence of causing injury to the rectum during surgery. The Trust advised that if they had missed an injury to the rectum during the surgery, they would expect the patient to present within two to three, at most four, days. Miss I presented 12 days post operatively. They explained that if there is a problem with infection, or the tissue dies, it takes around 10-14 days for the tissue to fall away and for a hole to appear.
28. Staff explained that a small area of tissue had died and broken down and said that this could have been caused by a small collection of blood (haematoma), meaning that this can cause enough pressure to stop the blood supply, and can take 7-10 days to make a small hole. The Trust concluded that the complications Miss I encountered were likely due to an infection that developed following the prolapse surgery, creating a rectovaginal fistula, rather than as the result of a direct injury at the time of surgery.
29. The records confirm the procedure was for posterior vaginal wall repair. Our adviser explained that in line with good clinical care, you would expect staff to have tightened the connective tissue with dissolvable sutures, as well as trimmed the excess skin prior to closure. We can see the procedure explained in the British Society of Urogynaecology patient leaflet which confirms this approach.
30. The operation notes, from 10 August 2017, describe an incision of the vaginal wall and tightening of the connective tissue with PDS (dissolvable) sutures, then trimming of the skin and closure. The adviser confirmed this suggests it was an entirely straightforward operation, conducted in a standard manner, with no suggestion of any complication.
31. Our adviser reflected that the Trust’s response confirmed a precautionary rectal examination at the end of the operation. This was to exclude any injury to the rectum which may have inadvertently occurred during the procedure. Our adviser confirmed that they would expect to see such an examination as part of essential surgery technique in vaginal surgery, to rule out injury.
32. On review, we could not see a specific reference to this in the records, but the Trust has since confirmed that a rectal exam was not documented at the end of the procedure, and that staff administered Per Rectum (PR) Voltarol to Miss I at the end of the procedure. The Trust says this involves a digital examination of the rectum at the same time, by the appropriately trained operating doctor.
33. Our clinical adviser explained that this in itself does not demonstrate an adequate examination was done. They referred to a Nursing Times article on rectal drug administration in adults, which says suppositories should be inserted around two to four centimetres into the anal canal. However, our adviser said for a thorough rectal examination you would expect a finger to be inserted about eight or nine centimetres into the rectum.
34. As such, while it is clear something was done, the aim and extent here meant it was a less thorough check than a rectal examination, which would instead check for suture or injuries, and would be more extensive. They accepted it could be done as part of the same process. However, the reference in the medical records focuses on the administration of the medication. They would have expected the surgeon to have specifically documented a PR examination for the purpose of excluding whether an injury to the rectum had taken place. There was no record of such an examination.
35. As such, we are not persuaded that there is sufficient evidence available to say that a digital rectal examination was conducted, which could have ruled out an injury to the rectum.
36. Overall, we have not seen any basis to suggest that a mistake was made in the conduct of the operation. However, we have seen a failing in the missed opportunity to rule out an injury to the rectum.
Information missing from leaflet
37. Miss I says that information the British Society of Urogynaecology (BSUG) sends to hospital trusts, relating to the risks of needing a colostomy bag, was not included in the patient information leaflet the Trust gave to her. She says this Trust is the only Trust that does not include information that this procedure comes with a risk of needing a colostomy bag, and she believes this should have been included.
38. The Trust noted that Miss I brought some information from BSUG to the local resolution meeting on 31 August, which does mention the risk of colostomy when talking about consent for the procedure she had. The BSUG leaflet, within the information the Trust provided is dated October, which post-dates Miss I’s operation. However, a previous leaflet from the BSUG’s website, dated May, also states colostomy as a risk. We know Miss I had consented to the procedure on 2 June. Staff agreed to take the Trust’s leaflet back to the Clinical Lead for Urogynaecology to discuss this further, and to look at whether they need to include information about colostomy during the consent procedure in the future. The Trust has since confirmed that, from September 2018, all clinicians at the Trust use the BSUG leaflet, and the newest version of which (dated October 2018) does mention the risk of colostomy bag.
39. Our adviser directed us to the GMC guidance on “Consent” (2008). This encourages the use of written preoperative information. In a letter sent before the surgery, dated 16 December, the doctor who saw Miss I mentions supply of a leaflet. The Trust has since provided the September version of the leaflet, which was in use at the time of Miss I’s operation. The leaflet mentions risk of bowel injury but does not specifically mention the risk of a colostomy bag, as we explained above.
40. The Trust was aware of the risks, and we do not dispute this. The Trust also accepts that this was not discussed, however, as explained above, the RCOG guidance at the time does not say this was necessary. Miss I has directed the Trust to the BSUG guidance, which we appreciate is a particular speciality of RCOG, and we have seen a copy of their May leaflet - although it is not clear if this is the one that she refers to or if the one she provided was from a later date. This leaflet does mention risk of a temporary colostomy bag, but neither this, nor the RCOG guidance (which was applicable at the time), mention the risk of a permanent colostomy bag.
41. With this in mind, given there was no requirement for staff to have specifically mentioned this to Miss I at the time, we could not criticize the Trust for this detail not being included in the patient information leaflet she received at the time. We therefore could not say that the Trust’s failure to include this information in its leaflet was a failing. However, we are pleased to see that from September 2018 this patient information leaflet was archived, and the Trust now use the BSUG (affiliated with the RCOG) patient information leaflet. This mentions temporary colostomy as an ‘exceptionally rare’ requirement.
Impact
42. We saw that the Trust did not carry out an appropriate rectal examination at the end of the procedure.
43. Miss I believes a mistake was made in the surgery, leading to her requiring a colostomy bag. The Trust say when Miss I presented on 23 August, having discovered the fistula, the Trust said they found a small defect and a broken stitch. We have therefore considered whether the failing may have been linked to the impact Miss I has described.
44. Our adviser explained that it is not possible to know exactly how the fistula occurred. They suggest it may have been due to inadvertent damage to the rectum during the operation, which is a risk no matter how carefully the surgery is conducted, or it may have been due to an infection in the area, as suggested in the Trust’s response. Miss I disputes this as she says when she was seen at another Trust days later, there was no evidence of infection.
45. Even if we were to obtain records from the other Trust to support that there was no infection, we could never say that the fistula occurred because of a mistake made in surgery. We understand that that the fistula occurred as a recognised complication of routine surgery and note there is always a risk that a person may experience a known complication. We therefore could not say that Miss I developing a fistula was because of a failing on the Trust’s part.
46. However, we do appreciate that if the rectal examination had taken place, and there had been an injury, our adviser considered that any such injury would likely have been discovered and dealt with. However, we cannot say now that there would have been an injury present at this time. As such, while we cannot say an injury was missed, we can say there was a missed opportunity for staff to clarify if there was an injury present or not.
47. We can say that as a result, Miss I will never know whether there was an injury at that point, and whether this could have been rectified. Accordingly, we appreciate she will now not know whether the colostomy bag could have been avoided, and we further appreciate the distress this has caused her.
48. As an outcome to her complaint, Miss I is looking for service improvements. Given the Trust says it carried out a rectal examination, it has not made any service improvements because of this. We consider it should make some service improvements to assure Miss I that this will not happen in future.
49. Miss I is also looking for a financial remedy. We can say that by not knowing if there was an injury at this point, or whether intervention could have rectified this, Miss I has been caused a moderate level of emotional distress, over a significant period of time. This is in line with level three of our severity of injustice scale.
50. We found two similar cases on our typology of injustice, both of which identified a missed opportunity to know if an earlier diagnosis was possible. We recommended £500, in relation to a missed opportunity to potentially diagnose and treat tinnitus, and £750, for a missed opportunity to potentially diagnose and treat an Achilles tendon rupture. Having considered the examples in both cases, the distress we consider Miss I has experienced appears to fall somewhere between the two. We therefore considered an amount of £625 (the middle point), to be appropriate in her case.