The effect of revision surgery (hiatus hernia repair, alone or with gastric bypass) on reflux in adults who have reflux after weight-loss sleeve gastrectomy

Participants are adults with gastro-oesophageal reflux following laparoscopic sleeve gastrectomy who undergo revision surgery as part of usual clinical care. Two revision approaches are used. For the purpose of this registration, the exposure group comprises participants undergoing laparoscopic hiatus hernia repair with conversion of the sleeve to a Roux-en-Y gastric bypass; the control group comprises participants undergoing laparoscopic hiatus hernia repair alone, described in the comparator field. Exposure arm: laparoscopic hiatus hernia repair with crural closure, followed by conversion of the sleeve gastrectomy to a Roux-en-Y gastric bypass. This is performed under general anaesthesia as a single operative episode, typically lasting two to three hours, and is not repeated. There is no ongoing study intervention after the operation. Allocation is not assigned by the study. The choice between the two approaches is made by the treating surgeon on clinical grounds, and all surgical and clinical care is delivered as usual care. Oesophageal acid exposure is measured by ambulatory pH or pH-impedance monitoring before revision surgery and once between 3 and 12 months after revision surgery. Catheter-based studies are recorded over 24 hours; catheter-free (Bravo) wireless studies are recorded over 48 hours. Patient-reported symptom (Visick) scores are collected before surgery and at 3, 6 and 12 months and 3 years after surgery.