Guidance
5 Safety
5 Safety
This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Mortality due to progressive respiratory insufficiency occurred at 3 months in 1 patient in a case series of 50 patients.
5.2 Myocardial infarction occurred at 6 months in 1 patient in the case series of 50 patients.
5.3 Gastric haemorrhage occurred in 1 patient in a case series of 100 patients (timing not stated). Patient had endoscopic coagulation but further details were not reported.
5.4 Postoperative gastric leaks occurred in 2% (2/100) of patients in the case series of 100 patients. One leak was visible with a barium swallow but uneventful, and the patient was discharged on the thirteenth day. One clinical leak was managed with an abdominal drain, and the patient was discharged after 5 weeks. Duodenal anastomotic leak (treated conservatively) occurred in 1 patient in the case series of 100 patients.
5.5 Haemoperitoneum occurred in 1 patient in a case series of 97 patients. Further details were not reported. Abdominal haematoma occurred in 3% (4/123) of patients in the case series of 123 patients. Further details were not reported.
5.6 Acute trocar site herniation occurred in 1 patient in the case series of 100 patients. The patient had another operation and prosthetic/mesh repair. Incarcerated umbilical hernia occurred in 1 patient in the case series of 97 patients. The patient had another operation.
5.7 Subphrenic abscess (drained under radiological guidance) occurred in 1 patient in the case series of 50 patients.
5.8 Stricture in the gastric sleeve (which led to dysphagia) needing dilatation occurred in 1 patient in the case series of 123 patients.
5.9 Reoperation due to early postoperative ulcer was needed in 1 patient in the case series of 123 patients.
5.10 Acute cholecystitis occurred within 1 year of the procedure in 4% (2/50) of patients in the case series of 50 patients. One patient had cholecystectomy and another patient was waiting to have surgery at the time of the report.
5.11 Clinical hypoalbuminemia occurred in 4% (4/100) patients in the case series of 100 patients. In 1 patient, it was related to severe diarrhoea and treated with metronidazole. In another patient it was due to intra-abdominal infection and the abscess was drained. In 2 other patients, it was due to reduced food intake; the patients were given counselling and their oral intake increased. Because of recurrent hypoproteinaemia, 2 of the patients had revision to the Roux‑en‑Y duodenal switch with a longer gut. Hypoalbuminemia was detected in 12% of patients, low vitamin A levels in 53% and high parathormone levels in 54% at 3 years follow-up in the case series of 97 patients.
5.12 Sporadic vomiting occurred in 1 patient in the case series of 50 patients. Further details were not reported.
5.13 Diarrhoea was reported in 2% (2/123) of patients in the case series of 123 patients. Further details were not reported.
5.14 Constipation was reported in 2% (2/123) of patients in the case series of 123 patients. Further details were not reported.
5.15 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers reported no anecdotal adverse events. They considered that the following were theoretical adverse events: malnutrition, vitamin and mineral deficiencies.