Clinical Trials Directory

Trials / Completed

CompletedNCT06070207

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (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. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. These studies are generally planned for unilateral hernias. It is a controversial issue among surgeons that the possibility of mesh migration is higher in bilateral hernias since there is a larger dissection area. This discussion is the starting point of this study. There were no studies in the literature regarding mesh fixation in bilateral inguinal hernias. The aim of this study is to compare bilateral inguinal hernia patients with and without mesh fixation in the eTEP technique in terms of both mesh migration and clinical features.

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
2023-01-01
Primary completion
2023-05-30
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 NCT06070207. Inclusion in this directory is not an endorsement.