Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT02811900

Recruiting nowNot applicableObservational

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionMorbid Obesity

Full registry criteria

Inclusion Criteria: * patient \>18 years old * BMI \> 35 kg/m² Exclusion Criteria: * Incapacity of giving an informed consent

Treatments and study arms

Roux en Y gastric bypass

Procedure

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.

Sleeve gastrectomy

Procedure

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.

Gastric banding

Procedure

Laparoscopic 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

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

Primary outcomes

Excess weight loss1 - 3 - 5 - 10 - 15 and 30 years

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Service de Chirurgie Digestive et Endocrinienne🇫🇷 Strasbourg, France
Didier Mutter, MD, PhDContact
Michel Vix, MDContact