Study Participants
duodenal or bile duct disease, Crohn’s disease
MAY, ADHESIONS
Patients referred to the surgical outpatient clinic for bariatric surgery at a county hospital in Sweden from Nov 2017 until May 2019 were eligible for inclusion. All patients fulfilled the indication for surgery (i.e., body mass index (BMI) ≥ 35 kg/mPatients eligible for surgery were invited to a group meeting and an individual appointment at the outpatient clinic as part of standard care, during which they received information about the surgical procedure and the study. Patients that were accepted for surgery were contacted by a nurse and given additional oral information about the study. Those who wanted to participate gave their oral consent during the call and were thereafter sent an informed consent form, the baseline study questionnaire, and an accelerometer. The signed consent, filled out questionnaire, and the accelerometer were returned to study personnel in a pre-paid envelope before surgery. Participants were randomized after surgery, independent of the surgical procedure that had been performed. The type of surgical procedure selected was decided up on as part of standard care. At the participating hospital, gastric bypass was the standard procedure, and sleeve gastrectomy was offered only to patients who were considered not suited for gastric bypass because of extensive adhesions in the lower abdomen, a history of Crohn’s disease, or duodenal or bile duct disease in need of endoscopic surveillance. Additional study questionnaires and accelerometers were sent out to participants 18 weeks post surgery and again after 6 and 12 months of follow-up. Figure Flow of participants and available data at baseline and follow-ups during the PromMera study