Morbid Obesity
Conditions
Keywords
obesity, surgical management, sleeve gastrectomy
Brief summary
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.
Detailed description
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)
Interventions
DRUGtisseel
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.
OTHERno tisseel
the surgeon does not applied tissucol during the surgery
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Obesity requiring bariatric surgery (Laparoscopic Sleeve Gastrectomy) according to the Haute Autorité de Santé * Patients younger than 60 years old * BMI ≤ 60 kg/m2 * Surgery accepted by an Obesity-related specific committee * Patient with social protection
Exclusion criteria
* Previous bariatric or gastric surgery * BMI \> 60 kg/m2 * Under 18 years old * Allergy to Tissucol® * peroperative fistula * Consent not signed * Incapable of giving his opinion * Pregnancy or breast-feeding * Contraindication to surgery * ASA classification IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presence of post-operative complications | post operative day 30 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The postoperative hemorrhage's rate | post-operative day 30 | — |
| The intra-abdominal locoregional collection's rate | post-operative day 30 | — |
| the length of stay | post-operative day 30 | — |
| the rate of readmission | post-operative day 30 | — |
| The gastric fistula's rate | post operative day 30 | — |
| the overall mortality at one month | post-operative day 30 | — |
| the specific mortality at one month | post-operative day 30 | — |
| the rate of postoperative morbidity | postoperative day 30 | the morbidity will be evaluated according to the clavien dindo classification |
| the rate of reintervention | post-operative day 30 | — |
Countries
France
Outcome results
None listed