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临床试验/NCT01645020
NCT01645020Unknown不适用

Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures

Western Galilee Hospital-Nahariya1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
1

研究概览

简要总结

Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.

详细描述

Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.

During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.

A polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.

The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.

排除标准

  • Women with significant pre-operative pain
  • Women with collagen diseases
  • Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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