NCT05152654

Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair

Completed NA Last updated 10 December 2021

What this trial tests

NA trial testing Tacker in Inguinal Hernia in 100 participants. Completed in 31 August 2021.

Timeline

1 December 2019

Primary endpoint
31 December 2020

31 August 2021

Quick facts

Lead sponsor	Hitit University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 December 2019
Primary completion	31 December 2020
Estimated completion	31 August 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Tacker

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →
• Pain, Acute — all drugs for Pain, Acute →
• Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

Hitit University

Who can join

Adults 18 to 90, any sex, with Inguinal Hernia or Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Until the last 20 years, after Lichtenstein described tension-free mesh hernia repair, this method was the gold standard in inguinal hernia surgery. This method was advantageous in terms of both less recurrence and less postoperative pain compared to tension methods. With the development of minimally invasive surgery, laparoscopic hernia surgery was first described by Dr. Ger in 1992. Laparoscopic inguinal hernia repair is based on the principles of preperitoneal repair described by Stoppa in open surgery. Its advantages over laparoscopic surgery are; Less post-operative pain, rapid recovery, reduction in nerve damage and chronic pain, and reduced recurrence rate. However, the disadvantage is that the learning curve is longer and higher cost. Two commonly used laparoscopic inguinal hernia surgeries are Trans Abdominal Pre-Peritoneal (TAPP) and totally extraperitoneal (TEP) methods. Although both are preperitoneal repair methods, less intraperitoneal organ damage, less intra-abdominal adhesion formation, and no need for peritoneal sheath repair are the advantages of the TEP method. For this reason, TEP method has been the preferred method today. Various methods have been tried in order not to change the location of the mesh placed in the TEP method. Laparoscopic inguinal hernia is one of the most debated issues. The most common methods for fixation are tacker, tissue adhesive, or suturing the mesh. However, fixing the mesh using a tacker can cause chronic pain. Tissue adhesives are not preferred because tissue adhesives have high costs and sometimes cause allergic reactions. The method in which the mesh is sewn to the pubic bone is avoided by surgeons because it prolongs the operation time. To avoid chronic pain after surgery, the idea was not to fix the mesh. The major drawback of this method is that the mesh may slip and cause recurrence.This study aimed to reveal the difference between the amount of migration and the amount of post-operative pain between detecting the mesh and not detecting it

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study.
   Yıldırım MB, Sahiner IT. · · 2023 · cited 10× · PMID 35286511 · DOI 10.1007/s10029-022-02587-w