Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery (Sleeve Gastrectomy )
• Interventions: Device: CLIP OST

• Registration Number: NCT01286714
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and the severity of the fistula. The management of this complication is still controversial and potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic management has to be improved to reduce the duration of the treatment and the number of endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a more prehensive, deeper and larger suture area.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• age upper to 18 years
• surgery bariatrique typical Sleeve
• presence of one or two fistulas < 1 cm, beforehand drained and without sepsis evolutionary
• signature of the consent

Exclusion Criteria

• surgery bariatrique other one than Sleeve
• refusal of the patient of this endoscopic repeated coverage(care) requiring several sessions of endoscopies under AG with hospitalizations
• Current Sepsis
• not drained cavity
• Absence of signed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clips OST	CLIP OST	-

Primary Outcome Measures

Name	Time	Method
The efficacity of closure of fistulas by clips ovesco	12 months

Secondary Outcome Measures

Name	Time	Method
The efficacity of the suture in 3 months of these complex refractory fistulas	12 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France