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

NCT06070207 | Completed

• 1 other identifier: 55555555555
• Study Type: interventional
• Target: 40
• 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. 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

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

• Rate of Postoperative complications

  postoperative 24 hours and 1st month

• Rate of Chronic pain

  postoperative 1st and 6th month

Study Arms (2)

TEP Group

ACTIVE COMPARATOR

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.

Procedure: TEP group

eTEP Group

EXPERIMENTAL

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.

Procedure: eTEP group

Interventions

TEP group PROCEDURE

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.

TEP Group

eTEP group PROCEDURE

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.

eTEP 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 bilateral 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,
• Recurrent hernias.
• Patients with unilateral 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)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain; Postoperative Complications; Recurrence

Condition Hierarchy (Ancestors)

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

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: September 29, 2023
• First Posted: October 6, 2023
• Study Start: January 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: April 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)