Ireland
--:--IST
Latest
Clinical Trials in France / NCT02811900
Recruiting Observational

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

NCT02811900 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
1996-01
Last updated
2017-11-09

Condition(s) studied

Morbid Obesity

Investigational drug(s) / intervention(s)

Roux en Y gastric bypassSleeve gastrectomyGastric bandingIntragastric balloon

Roux 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.

Sleeve 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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patient \>18 years old * BMI \> 35 kg/m² Exclusion Criteria: * Incapacity of giving an informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Service de Chirurgie Digestive et Endocrinienne Strasbourg France Recruiting

More IHU Strasbourg trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02811900 on ClinicalTrials.gov ↗ ← All trials in France