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Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01286714
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bariatric Surgery (Sleeve Gastrectomy ) Device: CLIP OST

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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 : January 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: clips OST Device: CLIP OST



Primary Outcome Measures :
  1. The efficacity of closure of fistulas by clips ovesco [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The efficacity of the suture in 3 months of these complex refractory fistulas [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286714


Locations
France
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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01286714     History of Changes
Other Study ID Numbers: 2010-A01210-39
2010-21 ( Other Identifier: AP HM )
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical