Comparison of Mesh Fixation and Non-Fixation in eTEP

NCT06417359 | Recruiting

• 1 other identifier: 65656565
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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 withmesh fixation and without mesh fixation laparoscopic eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.

Conditions

Migration of Implant; Pain; Postoperative Complications; Relapse

Outcome Measures

Primary Outcomes (1)

• Status of Mesh Displacement

  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.

  postoperative 24 hours, 1 and 6 months

Secondary Outcomes (4)

• Rate of Postoperative pain

  postoperative 24 hours

• Rate of Hernia recurrence

  postoperative 6th month and first year

• Rate of Postoperative complications

  postoperative 24 hours and 1st month

• Rate of Chronic pain

  postoperative 1st, 6th month and first year

Study Arms (2)

eTEP Mesh Fixation Group

ACTIVE COMPARATOR

In 30 patients; 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 be fixed to three absorbable tacker the Cooper ligament, süpermedially and laterally. 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.

Procedure: Mesh Fixation

eTEP No Mesh Fixation Group

EXPERIMENTAL

In 30 patients; 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 to the Cooper ligament. 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.

Procedure: No Mesh Fixation

Interventions

Mesh Fixation PROCEDURE

That mesh will be fixation with three tackers.

eTEP Mesh Fixation Group

No Mesh Fixation PROCEDURE

That mesh will not be fixation

eTEP No Mesh Fixation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral inguinal hernias,
• Patients aged 18-65.

You may not qualify if:

• Younger than 18 years, and older than 65 years,
• Incarcerated or strangulated inguinal hernias,
• Patients with bilateral inguinal hernias,
• Patients who are contraindicated to receive general anesthesia,
• Pregnancy

Sponsors & Collaborators

• Mehmet Eşref Ulutaş: lead
• Van Training and Research Hospital: collaborator

Study Sites (1)

University of Health Science Van Training and Research Hospital

Van, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Yildirim MB, Sahiner IT. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study. Hernia. 2023 Feb;27(1):63-70. doi: 10.1007/s10029-022-02587-w. Epub 2022 Mar 14.

  PMID: 35286511 RESULT

• Claus CMP, Rocha GM, Campos ACL, Paulin JAN, Coelho JCU. Mesh Displacement After Bilateral Inguinal Hernia Repair With No Fixation. JSLS. 2017 Jul-Sep;21(3):e2017.00033. doi: 10.4293/JSLS.2017.00033.

  PMID: 28904521 RESULT

• Claus CM, Rocha GM, Campos AC, Bonin EA, Dimbarre D, Loureiro MP, Coelho JC. Prospective, randomized and controlled study of mesh displacement after laparoscopic inguinal repair: fixation versus no fixation of mesh. Surg Endosc. 2016 Mar;30(3):1134-40. doi: 10.1007/s00464-015-4314-7. Epub 2015 Jun 20.

  PMID: 26092029 RESULT

• Yilmaz AH, Ulutas ME. Assessment of mesh displacement following laparoscopic enhanced view totally extraperitoneal technique: comparing mesh fixation and non-fixation in difficult inguinal hernias. Updates Surg. 2025 May 28. doi: 10.1007/s13304-025-02271-5. Online ahead of print.

  PMID: 40434603 DERIVED

MeSH Terms

Conditions

Pain; Postoperative Complications; Recurrence

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Disease Attributes

Central Study Contacts

Abdullah Hilmi Yılmaz, MD

CONTACT

0432 222 00 10; drabdullahhilmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: October 4, 2023
• Primary Completion: April 4, 2024
• Study Completion: October 4, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)