Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.
The hypothesis is the following : the use of fibrin glue (Tissucol ®) during Laparoscopic Sleeve Gastrectomy would reduce the incidence of complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection). The aim is to investigate whether the use of fibrin glue (Tissucol®) during Laparoscopic Sleeve Gastrectomy reduces the incidence of postoperative complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
597
The product will be given as a 2 mL bottle per patient, which will be spread along the staple line. If necessary, a second bottle of 2 mL is used. The precautions for use are described in the user manual.
the surgeon does not applied tissucol during the surgery
North Universitary Hospital
Amiens, France
Charles Nicolle Universitary Hospital
Rouen, France
presence of post-operative complications
The primary endpoint corresponds to the presence of complications after laparoscopic sleeve gastrectomy during the follow up period. A complication is considered as "present" if at least one of the following three items is present: * Gastric fistula * Postoperative hemorrhage * intra-abdominal locoregional collection
Time frame: post operative day 30
The gastric fistula's rate
Time frame: post operative day 30
The postoperative hemorrhage's rate
Time frame: post-operative day 30
The intra-abdominal locoregional collection's rate
Time frame: post-operative day 30
the length of stay
Time frame: post-operative day 30
the rate of readmission
Time frame: post-operative day 30
the rate of reintervention
Time frame: post-operative day 30
the overall mortality at one month
Time frame: post-operative day 30
the specific mortality at one month
Time frame: post-operative day 30
the rate of postoperative morbidity
the morbidity will be evaluated according to the clavien dindo classification
Time frame: postoperative day 30
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