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Completed

NCT Number: NCT06070142

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Science Van Training and Research Hospital

Van, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Status of Mesh Displacement

    Time frame: 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 outcomes

  1. Rate of Postoperative pain

    Time frame: 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.

  2. Rate of Hernia recurrence

    Time frame: 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.

  3. Rate of Postoperative complications

    Time frame: postoperative 24 hours and 1st month

    such as wound infection, bleeding

  4. Rate of Chronic pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mehmet Eşref Ulutaş

Other

Collaborators

  • Van Training and Research Hospital

Registry information

Official study title

Prospective Randomized Study of Comparison Mesh Displacement in Laparoscopic İnguinal Hernia Repair With No Fixation: eTEP Versus TEP

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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