Sprayshield as Adhesion Barrier System for Obese Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02142660

Acronym

Sprayshield

Enrollment

Registered

2014-05-20

Start date

2012-01-31

Completion date

2014-06-30

Last updated

2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Obesity

Keywords

Adhesion barrier system, Bariatric surgery

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.

Interventions

PROCEDUREablation 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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Duration of surgery	30 day surgical mortility	Duration of surgery 30 day surgical mortility

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026