RecruitingNCT02811900

An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study

An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study Internal Hernia After Laparoscopic Roux-en-Y Gastric Bypass: an Evaluation of the Impact on the Postoperative Course and a Quality of Life Case-control Study

Sponsor

IHU Strasbourg

Enrollment

10,000 participants

Start Date

Jan 1, 1996

Study Type

OBSERVATIONAL

Conditions

Morbid Obesity

Summary

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

Min Age: 18 Years

Inclusion Criteria2

patient >18 years old
BMI > 35 kg/m²

Exclusion Criteria1

Incapacity of giving an informed consent

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Interventions

PROCEDURERoux en Y gastric bypass

Laparoscopic 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.

PROCEDURESleeve gastrectomy

Laparoscopic 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.

PROCEDUREGastric banding

Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.

PROCEDUREIntragastric balloon

Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.