PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Incidence of incisional hernia at 12 months after laparotomy
研究概览
简要总结
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy. Participants will be randomized in a 1:1 ratio. The primary endpoint is the incidence of incisional hernia at 1 year. Secondary endpoints include postoperative complications, surgical site occurrences, pain, operative time, hospital stay, morbidity, mortality, quality of life, and long-term hernia incidence.
详细描述
Incisional hernia (IH) is a frequent complication after midline laparotomy, with rates up to 50-70% in high-risk or emergency settings. Emergency procedures are particularly prone to IH due to contamination and suboptimal conditions. Prophylactic mesh reinforcement has been shown to significantly reduce IH rates in elective surgery without increasing wound morbidity, but evidence in emergency settings is scarce. Biosynthetic meshes, with favorable safety and cost profiles in contaminated fields, may offer an effective preventive strategy.
The PREEMPT trial is a multicenter, randomized (1:1) controlled study including adult patients undergoing emergency midline laparotomy. Eligible patients will be randomized to prophylactic onlay biosynthetic mesh reinforcement versus primary suture closure. The primary outcome is the incidence of incisional hernia at 1 year. Secondary outcomes include postoperative complications, surgical site occurrences, pain (VAS), operative time, length of hospital stay, 30-day morbidity and mortality, readmission and reoperation rates, and long-term quality of life (SF-36) and hernia incidence at 2 and 3 years.
The PREEMPT trial is a multicenter randomized clinical trial of patients undergoing emergency laparotomy. We aim to evaluate whether prophylactic bio-synthetic mesh reinforcement could reduce the incidence of incisional hernia in patients undergoing emergency midline laparotomy compared with primary suture closure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.
排除标准
- •Age < 18 years
- •Minimally invasive surgery (laparoscopic or robotic approaches)
- •Elective surgery
- •Surgery requiring an open abdomen and its closure
- •Fecal peritonitis
- •Previous midline laparotomy
- •Pregnancy or breastfeeding
- •Conditions that would impair the possibility of understanding and giving of informed consent.
研究组 & 干预措施
Mesh-repair group
Patients randomized to this arm will receive prophylactic onlay placement of a biosynthetic mesh (poly-4-hydroxybutyrate mesh) to reinforce the abdominal wall closure at the time of laparotomy closure, in addition to standard surgical closure. A minimum overlap of 3 cm on all sides of the incision will be ensured. Mesh fixation will be achieved with four sutures placed at the cardinal points only.
干预措施: Prophylactic Biosynthetic Mesh Placement (Device)
Direct suture group
Patients randomized to this arm will receive standard abdominal wall closure according to European Hernia Society (EHS) guidelines: a slowly absorbable running suture will be used in all centers, employing a continuous small-bites technique. Tissue bites of 5-9 mm from the wound edges will incorporate the aponeurosis only, with stitches placed 5 mm apart to ensure uniform tension distribution, aiming for a suture length to wound length ratio of at least 4:1.
干预措施: Direct suture (Procedure)
结局指标
主要结局
Incidence of incisional hernia at 12 months after laparotomy
时间窗: 12 months after laparotomy
The primary outcome is the occurrence of incisional hernia within 12 months after laparotomy, assessed by clinical examination and/or imaging according to the study protocol. The incidence of incisional hernia will be compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.
次要结局
- Postoperative complications(Within 30 days after surgery)
- Incidence of surgical site infection(Within 30 days after surgery)
- Incidence of surgical site occurrences after emergency laparotomy(Within 30 days after surgery)
- Incidence of surgical site occurrences requiring procedural intervention (SSOPI)(Within 30 days after surgery)
- Incidence of incisional hernia at 2 and 3 years after surgery(At 2 and 3 years after surgery)
研究者
Andrea Divizia
MD, PhD
University of Rome Tor Vergata