Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study

Obesity is an independent risk factor for GERD and its complications. Bariatric surgery is effective in treatment of obesity and at the same time in controlling GERD, but there is disparity in current literature if sleeve gastrectomy could worsen it, more than gastric bypass. Our study aims to investigate if there is a difference in postoperative GERD between these two surgical procedures in obese patients with pre-existing GERD, defined by results of 24 hours pH monitoring, expressed by an abnormal DeMeester Score (DMS). REBvSS is a monocentric randomized controlled trial (RCT). The investigators will study 128 obese patients, eligible for Bariatric Surgery (BMS), suspected for GERD, with 24-h pH monitoring and high-resolution manometry. DMS is calculated pre-operatively and, once GERD is confirmed, the patients are randomized to SG or RYGBP. The DMS is then calculated on 24 hours pH monitoring 24 months after the surgery and the degree of GERD is evaluated. The promoter centre is the Division of Minimally invasive Oncological General Surgery at Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Lombardy, that is an excellence centre for bariatric and metabolic surgery according to Società Italiana di Chirurgia dell'Obesità e delle malattie metaboliche (SICOB) accreditation policy, where the study will be carried out.

Medical history will be collected during the first outpatient examination and assessed as follows:

* Diagnosis of Obesity, based on value of BMI ≥ 35; * Investigation of obesity-related diseases * Clinical, nutritional and surgical history * GERDQ score If the patient is eligible for BMS and there is the suspicion of GERD the preoperative evaluation will be carried out. It consists of a trial specific evaluation (EGDS, 24-h pH monitoring, HRM, DMS), that confirms the presence of GERD, and a standard evaluation (Ultrasonography of abdomen, ECG, Chest X-Ray, Blood exams, anesthaesiologic evaluation). When all the inclusion criteria are verified, the patient will be randomized to RYGBP or SG group and will undergo surgery. All patients will be randomized centrally using an online computer controlled permuted-block randomization module between SG and RYGBP in a 1:1 ratio.

The postoperative visits will be organised as follow:

* 90 days after surgery, to evaluate the presence or the absence of medical or surgical complications; * 12 months and 24 months after surgery EGDS, 24 hours pH-monitoring and HRM will be performed to evaluate the degree of esophagitis and calculate the DMS; the quality of life and the symptoms will be assessed troughs BAROS and GERDQ score; also the trend of comorbidities will be examined.

Every patient will be analysed according to the allocated treatment. The investigators hope that our study will finally answer this issue, thanks to its randomized nature and the definition of GERD based on gold standard pH monitoring. These findings might influence decision-making in bariatric surgery and change or confirm the success of sleeve gastrectomy, also for what concerns the reflux disease.

• Postoperative Gastroesophageal Reflux Disease (GERD) from baseline [Срок оценки: Change from baseline DeMeester Score 12 months after surgery]
• Postoperative reflux symptoms [Срок оценки: Baseline and 12 and 24 months from the surgery]
• Quality of life Questionnaire [Срок оценки: month 12 and 24 after surgery]
• Trend of the obesity-related diseases (Arterial hypertension, Type 2 Diabetes, continuous positive airway pressure (CPAP) use [Срок оценки: month 12 and 24 after surgery]
• Demographic [Срок оценки: Enrollment]
• Medical/Surgical complications [Срок оценки: day 90]