Comparison Between the Use of a Prophylactic Polypropylene Mesh and the "Small Bites" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Incidence of incisional hernia.
研究概览
简要总结
The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients meeting the inclusion criteria will be randomized 1:1 using random number generation in SPSS v.21, assigning them to either the Mesh or Bites group. Sealed opaque envelopes will be used just before the surgical intervention within the operating room. The envelope will be opened in the operating room upon initiation of midline laparotomy closure.
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
- •Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
- •Patients undergoing urgent laparoscopic surgery but necessitating conversion to midline laparotomy.
- •Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies.
- •Age over 18 years.
- •Signed informed consent (IC) from the patient and the investigator.
排除标准
- •Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
- •BMI ≥ 35 kg/m
- •Re-laparotomies.
- •Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
- •Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
结局指标
主要结局
Incidence of incisional hernia.
时间窗: One year surgery
Compare the incidence of midline laparotomy incisional hernia at one year post-surgery between the two groups: midline laparotomy closure using the "small bites" technique vs. midline laparotomy closure using the "small bites" technique supplemented with a suprapubic polypropylene mesh.
次要结局
- Incidence of wound infection(30 postoperative days)
- Morbidity and mortality rates(90 postoperative days)
研究者
Fernandez Zamora
Principal Investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta