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临床试验/NCT06070142
NCT06070142已完成不适用

Prospective Randomized Study of Comparison Mesh Displacement in Laparoscopic İnguinal Hernia Repair With No Fixation: eTEP Versus TEP

Mehmet Eşref Ulutaş2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Status of Mesh Displacement

研究概览

简要总结

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate.

One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation.

In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent without mesh fixation laparoscopic TEP and eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral inguinal hernias,
  • Patients aged 18-65.

排除标准

  • Younger than 18 years, and older than 65 years,
  • Incarcerated or strangulated inguinal hernias,
  • Recurrent hernias,
  • Patients with bilateral inguinal hernias,
  • Patients who are contraindicated to receive general anesthesia,
  • Pregnancy

结局指标

主要结局

Status of Mesh Displacement

时间窗: postoperative 24 hours, 1 and 6 months

Patients who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm.

次要结局

  • Rate of Hernia recurrence(postoperative 6th month)
  • Rate of Chronic pain(postoperative 1st and 6th month)
  • Rate of Postoperative complications(postoperative 24 hours and 1st month)
  • Rate of Postoperative pain(postoperative 24 hours)

研究者

发起方
Mehmet Eşref Ulutaş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehmet Eşref Ulutaş

Principal Investigator

Konya City Hospital

研究点 (2)

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