Sprayshield as Adhesion Barrier System for Obese Patients

Completed

• Conditions: Severe Obesity
• Interventions: Procedure: ablation of gastric

• Registration Number: NCT02142660
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The application of SprayShield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.

Detailed Description

Monocenter and observational study on 20 obese patients, requiring removal of the gastric band for poor results (weight regain or insufficient weight-loss) or mechanical complications of the band ( slippage, esophageal dilation) and schedule for a second step surgery of gastric bypass or sleeve gastrectomy 2 months later.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-05
• Status Verified: 2014-04
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Obese male or female who would benefit from a gastric band removal and for whom a second surgical step with conversion to sleeve gastrectomy or bypass is scheduled

Exclusion Criteria

• The patients having an ablation of ring motivated for an infectious complication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sprayshield	ablation of gastric	Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie

Primary Outcome Measures

Name	Time	Method
During the second surgical step the intensity of the adhesions in the operative field will be determined by the adhesion surface area and the adhesion intensity using	intra operative	During Conversion in Bypass or Sleeve Gastrectomy the intensity of the adhesions in the operative field will be determined by the adhesion surface area and the adhesion intensity using a 4-point : scale 0 (no adhesion), 1 (fine and esily detachable adhesions), 2 (thick vascularize adhesion), 3 (intense adhesion preventing the identification of cleavable plane between organs)

Secondary Outcome Measures

Name	Time	Method
Duration of surgery	30 day surgical mortility	Duration of surgery 30 day surgical mortility

Trial Locations

Locations (1)

Department of Digestive Surgery A, Saint Eloi Hospital; 🇫🇷 Montpellier, France