About this trial
1. To test if there is a significant differences between Oversewing versus surgical ligation clips for staple line reinforcement of the gastric pouch regarding the reduction of post operative bleeding and the need for blood transfusions in laparoscopic one anastomosis gastric bypass. 2. To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB). 3. To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency
Eligibility criteria
This trial accepts healthy volunteersQualifiers
✔ Age ≥ 18years old
Sex: both sex
Fit for bariatric surgery
body mass index (BMI) of 40 kg/m 2 or higher or BMI between 35 and 40 kg/m2 with significant comorbidities, such as T2DM, hypertension, OSAS or significant osteo- articular alterations, not responsive to medical therapies
Disqualifiers
Patients less than 18 years old
Patients or first guardians refused to participate in the current study
Patients or first guardians refused to provide informed written consent
All patients with bleeding disorders and patients needing re-exploration for bleeding other than staple line Pregnant or breastfeeding women
Trial design
Parallel
Treatments tested in this trial
Oversewing
Procedure/SurgeryThrough-and-through sutures with 3-0 absorbable monofilament sutures will be placed over the staple line to reinforce it in laparoscopic one anastomosis gastric bypass surgery.
Surgical Ligation Clips
Procedure/SurgeryTitanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Clinically Significant Postoperative Bleeding Within 30 Days
Proportion of participants experiencing clinically significant postoperative bleeding within 30 days of laparoscopic one-anastomosis gastric bypass. Clinically significant postoperative bleeding is defined as the occurrence of any of the following events within 30 days after surgery: 1. Re-operation for bleeding, 2. Endoscopic or radiologic intervention to control bleeding, 3. Transfusion of ≥ 1 unit of packed red blood cells for acute postoperative blood loss, or 4. Hemoglobin drop ≥ 2.0 g/dL from immediate postoperative baseline accompanied by hemodynamic instability (systolic blood pressure \< 90 mmHg or requiring vasopressor support). The analysis metric will be the number and percentage of participants (n, %) with at least one bleeding event in each treatment arm. Between-group comparison will use the risk difference with 95 % confidence interval (or the pre-specified statistical test per the statistical analysis plan).
Secondary outcomes
Operative Time
Duration of surgery measured in minutes from skin incision to skin closure. Analysis metric: mean (SD) operative time per group; compared using pre-specified statistical tests.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.