Morbid obesity. Other obesity
Conditions
Interventions
Intervention group: Reinforcing the staple line with polyglyconate and polydioxanone sutures during a laparoscopic sleeve gastrectomy.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: BMI = 40 kg/m², or = 35 kg/m² with at least one comorbidity such as obstructive sleep apnea, diabetes, hypertension, obesity hypoventilation syndrome, hyperlipidemia, Pickwickian syndrome, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis, severe urinary incontinence, impaired quality of life, disqualified from another surgery due to obesity like surgery for osteoarthritis or ventral hernia repair or stress urinary incontinence (SUI)
Exclusion criteria
Exclusion criteria: age less than 18 years old, BMI < 35 kg/ m², diseases of the digestive tract, history of bariatric surgery, fundoplication, coagulation disorders, severe anemia (hemoglobin < 5 g/dL), and use of corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomotic leakage. Timepoint: During the first 7 days and between the 1st and 6th week. Method of measurement: Radiographic evidence, reoperation to repair the anastomotic leak, percutaneous drain placement, endoscopic stent placement, abdominal abscess formation or antibiotic use for intra-abdominal abscess. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding. Timepoint: During the first 7 days and between the 1st and 6th week. Method of measurement: re-surgery for bleeding control, blood transfusion, unexplained hemoglobin drops to less than 10 g/dL, or unexplained hematocrit drops of more than 30% if there is no specific reason for it. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Gandominejad
Tehran University of Medical Sciences
Outcome results
None listed