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NCT Number: NCT07475169

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

Study Design and Rationale:

This study is a prospective, randomized, controlled clinical trial conducted at two high-volume tertiary bariatric centers. The aim is to evaluate whether irrigation of the gastric staple line with physiologically warm saline (37-40 °C) before performing omentopexy improves intraoperative hemostasis and reduces early postoperative bleeding following laparoscopic sleeve gastrectomy (LSG).

Irrigation of the operative field is standard practice during laparoscopic surgery to clear blood and enhance visualization. However, the effect of irrigation temperature on staple-line hemostasis in bariatric surgery has not been previously studied. Warm irrigation has demonstrated hemostatic and recovery benefits in other surgical specialties. This trial compares two clinically relevant strategies: warm saline versus conventional room-temperature saline.

Participants:

A total of 200 adult patients (18-60 years) undergoing primary LSG were enrolled. Inclusion criteria included BMI ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities. Patients with coagulopathy, recent anticoagulant use, prior major upper abdominal surgery, advanced organ failure, pregnancy, or inability to complete follow-up were excluded.

Randomization and Allocation:

Patients were randomized in a 1:1 ratio using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Surgeons were aware of the irrigation temperature, while postoperative assessors and patients were blinded to group allocation.

Intervention:

After completion of gastric transection using a 36-French bougie calibration, patients received:

  • Warm Irrigation Group: 400 mL sterile saline at 37-40 °C applied along the staple line.
  • Control Group: 400 mL sterile saline at 22-24 °C applied identically.

After irrigation and complete suctioning, the staple line was inspected and any active bleeding was controlled using bipolar cautery or clips. Standardized omentopexy was then performed in all patients using interrupted 2-0 PDS sutures spaced 2 cm apart.

No buttressing material, sealants, or additional reinforcement techniques were used in either group.

Primary Outcome:

Early postoperative bleeding within 48 hours, defined as any of the following:

  • Hemoglobin drop ≥ 2 g/dL
  • Drain output ≥ 150 mL sanguineous fluid within 24 hours
  • Clinical signs of bleeding
  • Need for endoscopic or surgical hemostasis

Secondary Outcomes:

  • Hemostasis-phase duration
  • Hemoglobin drop (continuous variable)
  • 24-hour drain output
  • Additional intraoperative hemostatic maneuvers
  • Postoperative pain scores
  • Postoperative nausea and vomiting
  • Length of hospital stay
  • 30-day complications (Clavien-Dindo classification)
  • Reoperation or readmission

Follow-up:

Patients were evaluated during hospitalization and followed at 1 week, 1 month, and 3 months postoperatively. All randomized patients completed follow-up and were included in intention-to-treat analysis.

Statistical Considerations:

Sample size was calculated to detect reduction in bleeding incidence from 15% to 5% with 80% power. Statistical significance was defined as p < 0.05.

This study evaluates a safe, inexpensive, and easily reproducible intraoperative modification that may improve staple-line hemostasis and early recovery after LSG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Warm Saline Irrigation

Procedure

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

Room Temperature Saline Irrigation

Procedure

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

Primary outcomes

  1. Incidence of early postoperative bleeding (composite outcome)

    Time frame: Within 48 hours after surgery

    Composite endpoint defined as the occurrence of any of the following within 48 hours after surgery:

    • Clinical evidence of bleeding
    • Hemoglobin drop ≥2 g/dL on postoperative day 1
    • Drain output >150 mL within 24 hours
    • Need for endoscopic or surgical hemostasis

Secondary outcomes

  1. Hemostasis-phase duration (minutes)

    Time frame: During surgery (intraoperative)

    Time required to achieve complete staple-line hemostasis after sleeve transection and prior to omentopexy (measured intraoperatively, in minutes).

  2. Additional intraoperative hemostatic maneuvers

    Time frame: During surgery (intraoperative)

    Proportion of participants requiring additional hemostatic maneuvers (e.g., bipolar coagulation and/or clipping) to control staple-line bleeding.

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

    Time frame: From preoperative baseline to postoperative day 1

    Change in hemoglobin level (g/dL) calculated as preoperative hemoglobin minus postoperative day 1 hemoglobin (continuous outcome).

  4. Drain output volume in the first 24 hours (mL)

    Time frame: Postoperative 0-24 hours

    Total drain output volume (mL) during the first 24 hours after surgery; measured every 8 hours and summed (continuous outcome).

  5. Postoperative pain intensity at 24 hours

    Time frame: 24 hours after surgery

    Pain intensity assessed at 24 hours after surgery using the Visual Analog Scale (0-10). Higher scores indicate worse pain.

  6. Postoperative nausea and vomiting (PONV) within 48 hours

    Time frame: Postoperative day 0 to day 2 (within 48 hours)

    Occurrence of postoperative nausea and/or vomiting and/or need for antiemetics in the early postoperative period.

  7. Length of hospital stay (days)

    Time frame: Perioperative

    Total duration of index hospitalization measured in days from the date of surgery to the date of hospital discharge. Reported as a continuous outcome (mean number of days).

  8. 30-day postoperative complications (Clavien-Dindo)

    Time frame: Within 30 days after surgery

    Binary outcome (Yes/No) indicating the occurrence of any postoperative complication within 30 days after surgery, classified according to the Clavien-Dindo system. The outcome is reported as the proportion of participants experiencing at least one complication.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Warm Staple-Line Irrigation (37-40 °C) Before Omentopexy Reduces Early Bleeding After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial

Acronym: WARM-LSG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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