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Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

This study is currently recruiting participants.
Verified March 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01286714
First received: January 28, 2011
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Bariatric Surgery (Sleeve Gastrectomy )
 Device: CLIP OST

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • The efficacity of closure of fistulas by clips ovesco [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The efficacity of the suture in 3 months of these complex refractory fistulas [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: January 2011
Estimated Study Completion Date: July 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clips OST Device: CLIP OST

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286714

Contacts
Contact: MARC BARTHET 04 91 96 87 37 marc.barthet@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: marc barthet         marc.barthet@ap-hm.fr    
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: direction de la recherche, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier: NCT01286714     History of Changes
Other Study ID Numbers: 2010-A01210-39, 2010-21
Study First Received: January 28, 2011
Last Updated: March 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on June 17, 2013