Warm Saline Irrigation Before Omentopexy to Reduce Early Bleeding After Laparoscopic Sleeve Gastrectomy
NCT07475169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-03-16
Summary
This prospective randomized clinical trial evaluates whether warming saline irrigation (37-40 °C) applied to the gastric staple line before performing omentopexy during laparoscopic sleeve gastrectomy (LSG) can reduce early postoperative bleeding compared with conventional room-temperature saline irrigation.
Staple-line bleeding remains one of the most relevant early complications after LSG and may lead to hemoglobin drop, prolonged drainage, blood transfusion, or re-intervention. Although reinforcement techniques such as oversewing or buttressing materials are commonly used, they may increase operative time and cost. Irrigation of the operative field is routinely performed during LSG to improve visualization; however, the potential effect of irrigation temperature on hemostasis has not been previously evaluated in bariatric surgery.
In this trial, 200 adult patients undergoing primary LSG were randomized in a 1:1 ratio to receive either warm saline irrigation (37-40 °C) or standard room-temperature saline irrigation (22-24 °C) applied directly to the staple line before omentopexy. All other operative steps were standardized.
The primary outcome is early postoperative bleeding within 48 hours. Secondary outcomes include hemoglobin drop, drain output, need for additional hemostatic maneuvers, operative efficiency, postoperative pain, length of hospital stay, and 30-day complications.
This study investigates a simple, low-cost, and easily applicable intraoperative modification that may enhance staple-line hemostasis and improve early recovery following LSG.
Conditions
- Postoperative Hemorrhage
- Obesity
Interventions
- PROCEDURE
-
Warm Saline Irrigation
Irrigation of the gastric staple line using warm saline (37-40°C) prior to omentopexy.
- PROCEDURE
-
Room Temperature Saline Irrigation
Irrigation of the gastric staple line using room-temperature saline prior to omentopexy.
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
Countries
- Egypt
Study Locations
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