Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Umbilical trocar site hernia incidence
研究概览
简要总结
A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.
详细描述
Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.
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, Investigator)
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
- •Age ≥ 18 years
- •Laparoscopic cholecystectomy
- •Emergent/elective
- •≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement
排除标准
- •Conversion to laparotomy
- •Emergent re intervention
- •Immunosuppression
- •Umbilical hernia
结局指标
主要结局
Umbilical trocar site hernia incidence
时间窗: 3 years
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
次要结局
- Seroma incidence(6 months)
- Hematoma incidence(6 months)
- Wound infection incidence(6 months)
- Pain presence(6 months, 1 and 3 years)
- Hospital discharge(48 hours)
- Return to regular activity(6 months)
- Surgeon satisfaction(3 years)
- Operative time(2 hours)
- Patient satisfaction(3 years)
研究者
Ana Ciscar
MD
Hospital de Mataró