Clinical Trials Directory

Trials / Completed

CompletedNCT06070142

Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Inguinal Hernia?

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Mehmet Eşref Ulutaş · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETEP GroupInguinal hernia surgery will be performed with the TEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.
PROCEDUREeTEP GroupInguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.

Timeline

Start date
2022-12-01
Primary completion
2023-04-01
Completion
2024-04-01
First posted
2023-10-06
Last updated
2024-05-14

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06070142. Inclusion in this directory is not an endorsement.