A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Incidence of incisional hernia
研究概览
简要总结
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.
A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.
The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both sexes aging less than 70 years old
排除标准
- •All procedures which will be performed on elective basis will be excluded
- •patients who are pregnant.
- •Patients on systemic steroid or chemotherapy
- •patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.
研究组 & 干预措施
Small bite
The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
干预措施: Small Bite (Procedure)
Large bite
The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
干预措施: Larger bite (Procedure)
结局指标
主要结局
Incidence of incisional hernia
时间窗: 12 months after surgery
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of surgery
Mansoura University