Sprayshield as Adhesion Barrier System for Obese Patients (Sprayshield)

December 30, 2014 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 342950
        • Department of Digestive Surgery A, Saint Eloi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sprayshield
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
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

What is the study measuring?

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
Time Frame: 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)
intra operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Jean Michel FABRE, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF8744

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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