Warm Staple-Line Irrigation (37-40 °C) Before Omentopexy Reduces Early Bleeding After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of early postoperative bleeding (composite outcome)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Warm Saline Irrigation
Warm saline irrigation (37-40°C) applied to the gastric staple line before omentopexy during laparoscopic sleeve gastrectomy.
干预措施: Warm Saline Irrigation (Procedure)
Room Temperature Saline
Standard room-temperature saline irrigation applied to the gastric staple line before omentopexy.
干预措施: Room Temperature Saline Irrigation (Procedure)
结局指标
主要结局
Incidence of early postoperative bleeding (composite outcome)
时间窗: Within 48 hours after surgery
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
次要结局
- 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)
- Postoperative nausea and vomiting (PONV) within 48 hours(Postoperative day 0 to day 2 (within 48 hours))
- Length of hospital stay (days)(Perioperative)
- 30-day postoperative complications (Clavien-Dindo)(Within 30 days after surgery)