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BariSurg trial

German BariSurg trial to assess SG vs. RYGB in BMI35-60

Recruitment started in November 2013

German researchers have begun a multi-centre, randomized controlled patient and observer blind trial to demonstrate excess weight loss (EWL) non-inferiority of SG compared to RYGB. The BariSurg trial was designed as a multi-centre, randomized controlled patient and observer blind trial, and will recruit 248 patients (124 patients assigned to each treatment arm). It is estimated that the recruitment period will be 18 months from the time the first patient is enrolled and the proposed duration of the entire trial is 90 months. Recruitment started in November 2013.

The primary endpoint is defined as EWL at 24 months after surgery (RYGB or SG). The trial’s major secondary endpoints will include morbidity, mortality, remission of obesity-related co-morbidities, GERD course and QoL. The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3–6, 12, 24, 36, 48 and 60 months postoperatively.

To be considered for enrolment, patients will be aged between 18 and 70 years old with a BMI35-60 with indication for bariatric surgery - patients with a BMI35-40 need to have at least one obesity-related co-morbidity such as T2DM or hypertension (Table 1). Patients will be asked to complete standard preoperative diagnostics including esophagogastroduodenoscopy (EGD), endocrine assessment and psychosomatics, and will also fill out four questionnaires (Short-Form-36 Health Survey (SF-36), Gastrointestinal Quality of Life Index (GIQLI), the Dumping questionnaire (Sigstad score) and Gastrointestinal Symptom Rating Score (GSRS).

Table 1: Inclusion and exclusion criteria

All patients will be assessed for dumping syndrome and if the diagnosis dumping syndrome is confirmed, patients will get the optimal treatment for dumping syndrome. For both bariatric procedures, nutritional supplementation might be necessary for the remainder of the patient’s life.

The BariSurg trial will be conducted at seven bariatric centres: the University of Heidelberg, Städtisches Klinikum Karlsruhe, Agaplesion Bethesda Krankenhaus Stuttgart, Schwarzwald-BaarKlinikum (Villingen-Schwenningen), Caritas-Krankenhaus St. Josef (Regensburg), Johanniter Krankenhaus (Bonn) and Sana Klinikum Offenbach GmbH (Offenbach).

To access this paper, please click here

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