Status:
COMPLETED
Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
Bichat Hospital
centre hospitalier de Compiegne
Conditions:
Gastrostomy
Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. The main complication is...
Detailed Description
Partially or fully covered stents are the most used method, but are not supported by any comparative studies. Their results are inconstant and the closure rate is estimated between 15 and 100%, with a...
Eligibility Criteria
Inclusion
- Any major patient hospitalized for a symptomatic fistula after sleeve gastrectomy, outside the exclusion criteria, is eligible.
- Free, informed and signed consent
- Affiliation to the social security system
Exclusion
- Other surgery than Sleeve gastrectomy
- Fistula located at a site other than the upper pole of the staple line
- Fistulization on the upper diaphragmatic floor
- Fistulous orifice larger than 25 mm
- Pregnancy
- Patient under guardianship or curators or deprived of public law
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04049955
Start Date
August 1 2019
End Date
November 1 2021
Last Update
January 18 2023
Active Locations (1)
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1
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, France, 80000