Clinical trial NCT06070142: Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Inguinal Hernia?
Official title: Prospective Randomized Study of Comparison Mesh Displacement in Laparoscopic İnguinal Hernia Repair With No Fixation: eTEP Versus TEP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migration of Implant
Pain
Postoperative Complications
Relapse
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
Collaborators: name: Van Training and Research Hospital
First posted: 2023-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Status of Mesh Displacement
timeFrame: postoperative 24 hours, 1 and 6 months
Secondary outcomes:
measure: Rate of Postoperative pain
timeFrame: postoperative 24 hours
measure: Rate of Hernia recurrence
timeFrame: postoperative 6th month
measure: Rate of Postoperative complications
timeFrame: postoperative 24 hours and 1st month
measure: Rate of Chronic pain
timeFrame: postoperative 1st and 6th month
Other outcomes:
Locations:
city: Van
country: Turkey
facility: University of Health Science Van Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.