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Clinical Trials/NCT06070142
NCT06070142
Completed
Not Applicable

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

Mehmet Eşref Ulutaş1 site in 1 country60 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Migration of Implant
Sponsor
Mehmet Eşref Ulutaş
Enrollment
60
Locations
1
Primary Endpoint
Status of Mesh Displacement
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
April 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mehmet Eşref Ulutaş
Responsible Party
Sponsor Investigator
Principal Investigator

Mehmet Eşref Ulutaş

Principal Investigator

Konya City Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Status of Mesh Displacement

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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