跳至主要内容
临床试验/NCT06533839
NCT06533839尚未招募不适用

Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)

Consorci Sanitari Integral2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
58
试验地点
2
主要终点
Postoperative parastomal hernia prevention

研究概览

简要总结

Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.

Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.

The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.

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
Single (Participant)

盲法说明

Single blinded

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing a definitive colostomy confection
  • Terminal colostomy confection
  • ASA index III or inferior
  • Patients who have given legat authorization to participate in the study

排除标准

  • Lateral colostomy or a colostomy that will be removed posteriorly

结局指标

主要结局

Postoperative parastomal hernia prevention

时间窗: up to one year post-intervention

proportion of Postoperative parastomal hernias

次要结局

  • morbidity(up to one year post-intervention)
  • Postoperative parastomal hernia prevention(5 years after surgery)
  • readmissions for complications(up to one year post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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