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IRCT20250109064325N1 IRCT 2025-02-15 Tehran University of Medical Sciences The Effect of Staple Line Reinforcement on Leakage and Bleeding Rates Following Laparoscopic Sleeve Gastrectomy The Effect of Staple Line Reinforcement on Leakage and Bleeding Rates Following Laparoscopic Sleeve Gastrectomy: A Multi-Center Study 2021-12-31 anticipated 107 Complete https://irct.ir/trial/81269 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Morbid obesity. Intervention group: Reinforcing the staple line with polyglyconate and polydioxanone sutures during a laparoscopic sleeve gastrectomy. Yes - There is a plan to make this available What will be shared: Data will be shared after blinding of datasheet. When: The data access period is 6 months after the results are published. To whom: Data will be accessible for researchers affiliated to universities. Conditions: Data can be used for further meta-analysis after permission of the person responsible for this project. Where to obtain: Data request should be sent through email for the person responsible for this project. Dr. Ali Gandominejad ali.gandominejad71@gmail.com How to obtain: Following the primary request, all the researchers will be informed by the responsible person and after permission the data will be shared. Comments:
public Ali Gandominejad
Imam Khomeini hospital surgery ward, Keshavarz blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2618 ali.gandominejad71@gmail.com Tehran University of Medical Sciences scientific Ali Gandominejad
Imam Khomeini hospital surgery ward, Keshavarz blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2618 ali.gandominejad71@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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) 18 years no limit Both 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 E66.8 Other obesity Treatment - Devices Intervention group: Reinforcing the staple line with polyglyconate and polydioxanone sutures during a laparoscopic sleeve gastrectomy 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. 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. Tehran University of Medical Sciences Approved 2021-12-01 Tehran university of medical sciences ethics committee Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)