跳至主要内容
临床试验/NCT00908661
NCT00908661已完成不适用

Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done

研究概览

简要总结

The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

详细描述

Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.

Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.

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
Single (Outcomes Assessor)

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 with permanent ostomy and 1 years of life expectancy
  • •Signed informed consent

排除标准

  • •Allergy to the compounds of the mesh
  • •Rejection of the patient
  • •Rejection of the surgeon
  • •Field of emergency
  • •Life expectancy < 1 year
  • •Prior meshes in the surgical site

研究组 & 干预措施

Prophylactic mesh

Active Comparator

All patients will have a permanent ostomy and a randomisation with prophylactic mesh

干预措施: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh (Device)

without prophylactic mesh

No Intervention

All patients will have a permanent ostomy and a randomisation without prophylactic mesh

结局指标

主要结局

If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done

时间窗: 24 to 36 months after surgery

次要结局

  • Measuring the quality of life using the SF-36(Preoperative and at the end of the study)

研究者

研究点 (1)

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