Warm Saline Irrigation Before Omentopexy to Reduce Early Bleeding After Laparoscopic Sleeve Gastrectomy

NCT07475169 | Completed

• 1 other identifier: FMASU-REC-49/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

laparoscopic sleeve gastrectomy; warm saline irrigation; staple line; omentopexy; postoperative bleeding; bariatric surgery; randomized clinical trial; hemostasis

Outcome Measures

Primary Outcomes (1)

• Incidence of early postoperative bleeding (composite outcome)

  Composite endpoint defined as the occurrence of any of the following within 48 hours after surgery: 1. Clinical evidence of bleeding 2. Hemoglobin drop ≥2 g/dL on postoperative day 1 3. Drain output \>150 mL within 24 hours 4. Need for endoscopic or surgical hemostasis

  Within 48 hours after surgery

Secondary Outcomes (8)

• Hemostasis-phase duration (minutes)

  During surgery (intraoperative)

• Additional intraoperative hemostatic maneuvers

  During surgery (intraoperative)

• Hemoglobin drop (ΔHb) from baseline to postoperative day 1 (g/dL)

  From preoperative baseline to postoperative day 1

• Drain output volume in the first 24 hours (mL)

  Postoperative 0-24 hours

• Postoperative pain intensity at 24 hours

  24 hours after surgery

Study Arms (2)

Warm Saline Irrigation

EXPERIMENTAL

Warm saline irrigation (37-40°C) applied to the gastric staple line before omentopexy during laparoscopic sleeve gastrectomy.

Procedure: Warm Saline Irrigation

Room Temperature Saline

ACTIVE COMPARATOR

Standard room-temperature saline irrigation applied to the gastric staple line before omentopexy.

Procedure: Room Temperature Saline Irrigation

Interventions

Warm Saline Irrigation PROCEDURE

Irrigation of the gastric staple line using warm saline (37-40°C) prior to omentopexy.

Warm Saline Irrigation

Room Temperature Saline Irrigation PROCEDURE

Irrigation of the gastric staple line using room-temperature saline prior to omentopexy.

Room Temperature Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• BMI ≥ 40 kg/m², or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea)
• Eligible for primary laparoscopic sleeve gastrectomy
• Provided written informed consent

You may not qualify if:

• Previous major upper abdominal surgery with expected adhesions
• Known bleeding disorders
• Use of anticoagulant or antiplatelet therapy within 7 days before surgery
• Advanced hepatic or renal disease
• Unstable cardiac conditions
• Pregnancy
• Immunosuppression
• Active systemic infection
• Inability to comply with follow-up schedule

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Postoperative Hemorrhage; Obesity

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, parallel-group clinical trial. Participants undergoing laparoscopic sleeve gastrectomy are randomly assigned in a 1:1 ratio to receive either warm saline irrigation (37-40°C) of the staple line before omentopexy or standard room-temperature saline irrigation. Outcomes are compared between the two independent groups.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 16, 2026
• Study Start: December 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)