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

NCT02811900 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2017-11-09

No results posted yet for this 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).

Conditions

  • Morbid Obesity

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

Intragastric balloon

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

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Didier Mutter, MD, PhD · Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-01-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811900 on ClinicalTrials.gov