NCT07475169Completed
Warm Saline Irrigation Before Omentopexy to Reduce Early Bleeding After Laparoscopic Sleeve Gastrectomy
Warm Staple-Line Irrigation (37-40 °C) Before Omentopexy Reduces Early Bleeding After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 12 Feb 2026
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Ain Shams University
- Diseases
- Obesity
- NCT number
- NCT07475169
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 1 Dec 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major upper abdominal surgery with expected adhesions
- Use of anticoagulant or antiplatelet therapy within 7 days before surgery
Other illness
- Known bleeding disorders
- Advanced hepatic or renal disease
- Unstable cardiac conditions
- Active systemic infection
Other
- Pregnancy
- Immunosuppression
- Inability to comply with follow-up schedule
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.