Sprayshield as Adhesion Barrier System for Obese Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study Evaluating the Usefulness of Sprayshield as Adhesion Barrier System in Two Steps Laparoscopic Bariatric Surgery for Obese Patients

Conditions
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Severe Obesity

Intervention / Treatment
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* Procedure: ablation of gastric


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sprayshield<br>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 | Procedure: ablation of gastric<br>* 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 in wing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | intra operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | Duration of surgery 30 day surgical mortility | 30 day surgical mortility | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesion barrier system, Bariatric surgery