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临床试验/NCT04749329
NCT04749329招募中不适用

Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy

Azienda Sanitaria Locale Napoli 2 Nord4 个研究点 分布在 1 个国家目标入组 110 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
招募中
入组人数
110
试验地点
4
主要终点
Rate of Parastomal Hernia at clinical control.

研究概览

简要总结

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

详细描述

Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia.

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

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)

盲法说明

Patients were randomized in two groups (Control Group, without mesh; Mesh Group, receiving Bio-A mesh supported colostomy in an ante rectus fashion). Participants were randomly allocated to one of the two groups using computer-generated permuted blocks (www.randomization.com), just before colostomy fashion. For each patient, an identification number was generated. This latter was utilized during all the follow-up period guarantying the blinding process. Patients, care providers, staff collecting data and those assessing the endpoints, in fact, we're all blinded to group allocation. Because the blinding of the operating surgeons was not feasible, they were not involved in the

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

  • age > 18 years
  • endo colostomy
  • Informed consent

排除标准

  • age < 18 years;
  • life expectancy < 24 months (as estimated by the operating surgeon)
  • pregnancy
  • immunosuppressant therapy within 2 weeks before surgery

结局指标

主要结局

Rate of Parastomal Hernia at clinical control.

时间窗: 24 months

Detect of paratoia hernia

次要结局

  • Number of patients affected by Superficial surgical site infections(Within 30 days postoperatively)
  • Number of patients affected by Deep surgical site infections(Within 30 days postoperatively)
  • Rate of Parastomal Hernia at tomography observation.(24 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pizza

Head of Bariatric Unit

Azienda Sanitaria Locale Napoli 2 Nord

研究点 (4)

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