NCT06070207

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

Completed NA Last updated 14 May 2024

What this trial tests

NA trial testing TEP group in Migration of Implant in 40 participants. Completed in 1 April 2024.

Timeline

1 January 2023

Primary endpoint
30 May 2023

1 April 2024

Quick facts

Lead sponsor	Mehmet Eşref Ulutaş
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 January 2023
Primary completion	30 May 2023
Estimated completion	1 April 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• TEP group
• eTEP group

Conditions studied

• Migration of Implant — all drugs for Migration of Implant →
• Pain — all drugs for Pain →
• Postoperative Complications — all drugs for Postoperative Complications →
• Relapse — all drugs for Relapse →

Sponsor

Mehmet Eşref Ulutaş

Who can join

Adults 18 to 65, any sex, with Migration of Implant or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.