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

Not Applicable

Completed

• Conditions: Migration of Implant; Pain; Postoperative Complications; Relapse
• Interventions: Procedure: TEP group; Procedure: eTEP group

• Registration Number: NCT06070207
• Lead Sponsor: Mehmet Eşref Ulutaş

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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-05-30
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-09-30
• Study First Posted: 2023-10-06
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with bilateral 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 unilateral inguinal hernias.
• Patients who are contraindicated to receive general anesthesia.
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEP Group	TEP group	In 20 patients; Bilateral inguinal 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. During the surgery, the mesh will not be fixed. Patients whose pain scores (VAS score) are measured on the first postoperative day and 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, their pain scores will be measured (VAS score) and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm.
eTEP Group	eTEP group	In 20 patients; Bilateral inguinal 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. During the surgery, the mesh will not be fixed. Patients whose pain scores (VAS score) are measured on the first postoperative day and 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, their pain scores will be measured (VAS score) and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm.

Primary Outcome Measures

Name	Time	Method
Status of Mesh Displacement	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 Outcome Measures

Name	Time	Method
Rate of Chronic pain	postoperative 1st and 6th month	It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.
Rate of Postoperative complications	postoperative 24 hours and 1st month	such as wound infection, bleeding
Rate of Postoperative pain	postoperative 24 hours	It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.
Rate of Hernia recurrence	postoperative 6th month	hernia recurrence after six months of follow-up. It will be checked by physical examination. Imaging methods will be used in suspicious cases.

Trial Locations

Locations (1)

University of Health Science Van Training and Research Hospital; 🇹🇷 Van, Turkey