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临床试验/NCT02233465
NCT02233465已完成1 期

Mesh-repair With Inraperitoneal On-lay Mesh (IPOM) for Parastomal Hernia

Norrbottens Lans Landsting0 个研究点目标入组 50 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
50
主要终点
Parastomal recurrence rate

研究概览

简要总结

Parastomal herniation is difficult to treat. Several different treatment has been tested but still none has revealed to be superior. The use of a mesh has been shown to be a promising way of treating. In this study the investigators will evaluate safety and hernia recurrence rate with a mesh tailored to treat parastomal hernias "Parastomal hernia mesh BARD" in patients with parastomal hernia requiring surgery.

详细描述

Parastomal hernia is a common complication in patients with a stoma and may cause the patient difficulties with stomal dressing and leakage of stomal content, as well as pain and risk for incarceration. The exact hernia incidence is not known, it depends on the definition of whether a bulge is considered a hernia or not, as well as the duration of follow-up. The reported incidence ranges between 0 and 52%. The majority of parastomal hernias develop within a few years after the index operation, but can appear as late as 20 years after surgery.

There is no superior treatment for an existing parastomal hernia. Several methods have been tested and used such as stoma relocation, sutures to narrow the opening in the fascia and abdominal wall and fixation and closure of the lateral space but none has proven to prevent from recurrence of herniation. Mesh repair has been shown to give a lower recurrence rate 0-33%. No technical factor, such as site of stoma formation (through or lateral to rectus abdominis muscle), related to the construction of the stoma was proven to prevent hernia formation.

To find a way to prevent the occurrence of parastomal hernia is an important issue. Today there are reports proposing a mesh in sublay position at the index operation would prevent hernia formation. Although the results are promising these studies are small and they do not meet the issue late complications according to the mesh implant.

The use of intraperitoneal on-lay mesh (IPOM) is widely used to treat incisional hernia. A new mesh (Parastomal hernia mesh BARD) has been tailored to treat parastomal hernia. To evaluate safety and hernia recurrence rate using the BARD-mesh for treating parastomal hernia a prospective multicentre non-randomised study is performed. The aim is to include 50 patients in the study.

Patients with parastomal hernia requiring surgery due to leakage, problems with stoma dressing, bulging, incarceration and other problems related to the hernia will be offered enrollment in the study after informed consent. The preoperative examination include clinical examination, three dimensional ultrasonography (3D) and or computed tomography (CT) of the abdomen.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Parastomal hernia requiring surgery, over the age of 18

排除标准

  • Patient not accepting participation

结局指标

主要结局

Parastomal recurrence rate

时间窗: One year and three year

次要结局

  • Complications(three months, one year and three year)

研究者

发起方
Norrbottens Lans Landsting
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pia Nasvall

MD

Norrbottens Lans Landsting

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