Efficacy of Oversewing Versus Surgical Ligation Clips for Staple Line Reinforcement of the Gastric Pouch to Reduce Post Operative Bleeding in Laparoscopic One Anastomosis Gastric Bypass

Condition(s) studied

Investigational drug(s) / intervention(s)

Oversewing: Through-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: Titanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery.

Study summary

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

Primary outcome measure(s)

• Incidence of Clinically Significant Postoperative Bleeding Within 30 Days — 30 days after laparoscopic one-anastomosis gastric bypass surgery
  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).

Trial sites (1)

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