Clinical study evaluating the usefulness of fibrin glue (TISSEEL) to prevent gastric fistula, intra abdominal haemorrhage and intra abdominal loco regional collections after Laparoscopic sleeve Gastrectomy
- Conditions
- morbid obesitysleeve gastrectomyMedDRA version: 16.1Level: LLTClassification code 10027966Term: Morbid obesitySystem Organ Class: 100000004861MedDRA version: 16.1Level: PTClassification code 10059610Term: Obesity surgerySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-001361-16-FR
- Lead Sponsor
- CHU AMIENS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method