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Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

NCT ID: NCT01286714

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Bariatric Surgery (Sleeve Gastrectomy )

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clips OST

Group Type EXPERIMENTAL

CLIP OST

Intervention Type DEVICE

Interventions

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CLIP OST

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2010-21

Identifier Type: OTHER

Identifier Source: secondary_id

2010-A01210-39

Identifier Type: -

Identifier Source: org_study_id