About 2 % of the Norwegian adult population suffers from morbid obesity. Due to limited long-term weight loss after non-surgical treatment, various surgical techniques (bariatric surgery) have been developed. The Roux-en-Y gastric bypass, a combined restrictive and malabsorptive procedure, is the most commonly performed bariatric procedure both in Norway and worldwide. Vertical (sleeve) gastrectomy is a purely restrictive procedure. In the “Obesity Surgery in Tønsberg-study” (OSEBERG-study) patients with morbid obesity and type 2 diabetes are randomized to either gastric bypass or sleeve gastrectomy.
The primary outcome of the OSEBERG-study is beta-cell function and glycemic control one year post operation. The participants in OSEBERG have severe obesity and type 2 diabetes. Both diseases are associated with impaired quality of life, impaired gastrointestinal quality of life and a high prevalence of gastroesophageal reflux disease (GERD) and esophageal motility disorders. The physiological mechanisms explaining gastrointestinal symptoms in subjects with obesity and/or diabetes are, however, poorly understood. One major concern related to sleeve gastrectomy is the increased risk for gastroesophageal reflux disease (GERD) following the operation. The effect of sleeve gastrectomy on GERD remains controversial, and studies addressing both objective and subjective measures of GERD are needed.
The main aim of the present randomized controlled study (OSEBERG Reflux) is to compare the long-term (1-year) effects of gastric bypass and sleeve gastrectomy on postoperative GERD symptoms and objective findings. The secondary aims are, first, to increase the understanding of how gastrointestinal quality of life, GERD and motility disorders are affected by type 2 diabetes in severely obese patients, and, second, to assess the extent to which subjective symptoms correlate with the objective endoscopic findings of GERD and esophageal motility disorders.
