Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Fascial dehiscence incidence
研究概览
简要总结
Facial dehiscence elicit high morbidity and mortality. This complication may arise in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on the incidence of fascial dehiscence in emergency surgery and associated complications.
详细描述
Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more than 8.5% of high-risk patients. Current preventive measures described are control of risk factors and optimization of surgical technique. Despite that, the incidence of such complication remained stable in the last decades, highlighting the low efficacy of such measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected elective patients, and could be useful in the prevention of fascial dehiscence. In emergency situations, especially in contaminated and infected surgical procedures, safety and efficacy of mesh is controversial. In this study the investigators aimed to evaluate the influence of polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk patients undergoing midline emergency laparotomy. As secondary outcome, the associated morbidity, including surgical site occurence, will be analyzed. The study design will be a randomized controlled trial.
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
- Single (Care Provider)
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
- •Emergency laparotomy by midline incision
- •High risk for abdominal wound dehiscence: Risk index** ≥ 4,0 or ≥ 2,2 in combination with at least one of the following: smoking, obesity, malnutrition or malignant neoplasia.
- •Risk index is the sum of values associated with high-risk characteristics, based in the risk score for abdominal wall dehiscence published by van Ramshorst et. al. in World Journal of Surgery, 2010 (Rotterdam risk model):
- •Age category (in years)
- •40-49: 0.4
- •50-59: 0.9
- •60-69: 0.9
- •Male gender: 0.7
- •Chronic pulmonary disease: 0.7
- •Ascites: 1.5
- •Jaundice: 0.5
- •Anemia: 0.7
- •Emergency surgery: 0.6
- •Type of surgery:
- •Gallbladder/bile duct 0.7
- •Esophagus 1.5
- •Gastroduodenum 1.4
- •Small bowel 0.9
- •Large bowel 1.4
- •Vascular 1.3
排除标准
- •Non-midline incisions or midline laparotomy measuring less than 1/4 the distance between the xyphoid and the pubis, including laparoscopic surgery.
- •Diagnosis of incisional hernia or presence of previous mesh on site.
- •Midline laparotomy performed in less than 30 days.
- •Pregnancy
- •Severe trauma with hemodynamic instability
- •Need for open abdomen or relaxing incisions
- •Need for re-laparotomy during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed.
- •Death during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed before the event.
研究组 & 干预措施
Suture group
Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure.
干预措施: Midline Fascial Closure (Procedure)
Prophylactic mesh group
Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.
干预措施: Midline Fascial Closure (Procedure)
Prophylactic mesh group
Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.
干预措施: prophylactic polypropilene mesh (Device)
Prophylactic mesh group
Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.
干预措施: vacuum drainage system (Device)
结局指标
主要结局
Fascial dehiscence incidence
时间窗: 30 days
次要结局
- Surgical site occurence (SSO) incidence(30 days or during hospital stay)
- Intensive care unit length of stay (days)(30 days)
- Surgical site occurrence requiring procedural intervention (SSOPI) incidence(30 days or during hospital stay)
- Operative time (minutes),(30 days)
- Hospital length of stay (days)(30 days)
研究者
Edivaldo Massazo Utiyama
MD, PhD, Full Professor of Surgery
University of Sao Paulo General Hospital