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Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Primary Purpose

Bariatric Surgery (Sleeve Gastrectomy )

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CLIP OST
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery (Sleeve Gastrectomy )

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clips OST

Arm Description

Outcomes

Primary Outcome Measures

The efficacity of closure of fistulas by clips ovesco

Secondary Outcome Measures

The efficacity of the suture in 3 months of these complex refractory fistulas

Full Information

First Posted
January 28, 2011
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01286714
Brief Title
Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery
Official Title
Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery (Sleeve Gastrectomy )

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clips OST
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CLIP OST
Primary Outcome Measure Information:
Title
The efficacity of closure of fistulas by clips ovesco
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The efficacity of the suture in 3 months of these complex refractory fistulas
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

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