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临床试验/NCT05466084
NCT05466084已完成不适用

A Randomized Controlled Trial Studying Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

University of Jordan2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

This is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

详细描述

Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all.

This is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all Adult Patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias.

排除标准

  • operations which were converted from TAPP to other procedures (such as open repair or TEP).
  • Patients who were unfit for general anesthesia
  • patients who refused to participate in the study
  • patients with chronic pain disorders requiring long term pain management before the procedure.
  • cases with complicated hernias that required emergency repair.

结局指标

主要结局

postoperative pain

时间窗: 6 weeks

postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10

次要结局

  • hospital stay(6 WEEKS)
  • postoperative complications(6 weeks)
  • operative time(intraoperative)

研究者

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

Hanan Ibrahim Mansour

General surgery specialist

University of Jordan

研究点 (2)

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