About this trial
A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization.
A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patient >18 years old
BMI > 35 kg/m²
Disqualifiers
Incapacity of giving an informed consent
Trial population
Patient \>18 years old BMI \>35 kg/m²
Trial design
Cohort
Prospective
Treatments tested in this trial
Roux en Y gastric bypass
Procedure/SurgeryLaparoscopic RYGB is performed as following: a gastric pouch of approximately 30mL was obtained using successive firings of the Endo GIATM linear stapler, followed by the creation of an antecolic alimentary limb of 150cm and of a biliopancreatic limb of 75cm. A gastrojejunal anastomosis was fashioned with the PCEEA™ 28 circular stapler until 2012, and using the Endo GIA™ linear stapler afterwards. The mesenteric defect and Petersen's defect were closed using a non-absorbable running suture.
Sleeve gastrectomy
Procedure/SurgeryLaparoscopic SG is performed as following: after greater curvature mobilization, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using successive firings of 3.5- or 4.8-mm-high staples, depending on gastric thickness.
Gastric banding
Procedure/SurgeryLaparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.
Intragastric balloon
Procedure/SurgeryFlexible endoscopy is used to place intragastric balloon for a maximum interval of six months.
Treatment groups
Trial outcomes
Primary outcomes
Excess weight loss
Secondary outcomes
BMI
Albumin
Albumin
Pre-albumin
Pre-albumin
Vitamin A
Vitamin A
Sponsors and contacts
Click on the lead sponsor to view all of their trials.