Clincosm LogoSign in Get a demo

Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT01286714
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
32
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CLIP OST
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: clips OST

Device: CLIP OST

Outcome Measures

Primary Outcome Measures

  1. The efficacity of closure of fistulas by clips ovesco [12 months]

Secondary Outcome Measures

  1. The efficacity of the suture in 3 months of these complex refractory fistulas [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hopitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: BERNARD BELAIGUES, Assistance Publique hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01286714
Other Study ID Numbers:
  • 2010-A01210-39
  • 2010-21
First Posted:
Jan 31, 2011
Last Update Posted:
Aug 29, 2014
Last Verified:
Aug 1, 2014
Additional relevant MeSH terms:
Fistula

Study Results

No Results Posted as of Aug 29, 2014