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Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286714
First Posted: January 31, 2011
Last Update Posted: August 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Resource links provided by NLM:


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 ]

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

Enrollment: 15
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clips OST Device: CLIP OST

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: January 28, 2011
First Posted: January 31, 2011
Last Update Posted: August 29, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical