## Protocol Section
### Identification Module
**NCT ID:** NCT06417359

**Brief Title:** Comparison of Mesh Fixation and Non-Fixation in eTEP

**Official Title:** Comparison of Mesh Fixation and Non-Fixation in Laparoscopic eTEP Inguinal Hernia Repair

#### Organization Study ID Info
**ID:** 65656565
#### Organization
**Class:** OTHER
**Full Name:** Konya City Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04-04

**Type:** ACTUAL

#### Start Date
**Date:** 2023-10-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Van Training and Research Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Mehmet Eşref Ulutaş

#### Responsible Party

**Investigator Affiliation:** Konya City Hospital

**Investigator Full Name:** Mehmet Eşref Ulutaş

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Migration of Implant

- Pain

- Postoperative Complications

- Relapse

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Mesh Fixation

**Label:** eTEP Mesh Fixation Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: No Mesh Fixation

**Label:** eTEP No Mesh Fixation Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- eTEP Mesh Fixation Group

**Description:** That mesh will be fixation with three tackers.

**Name:** Mesh Fixation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- eTEP No Mesh Fixation Group

**Description:** That mesh will not be fixation

**Name:** No Mesh Fixation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Status of Mesh Displacement

**Time Frame:** postoperative 24 hours, 1 and 6 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Rate of Postoperative pain

**Time Frame:** postoperative 24 hours

**Description:** hernia recurrence after six months of follow-up. It will be checked by physical examination. Imaging methods will be used in suspicious cases.

**Measure:** Rate of Hernia recurrence

**Time Frame:** postoperative 6th month and first year

**Description:** such as wound infection, bleeding

**Measure:** Rate of Postoperative complications

**Time Frame:** postoperative 24 hours and 1st month

**Description:** 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.

**Measure:** Rate of Chronic pain

**Time Frame:** postoperative 1st, 6th month and first year

### Eligibility Module

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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drabdullahhilmi@gmail.com

**Name:** Abdullah Hilmi Yılmaz, MD

**Phone:** 0432 222 00 10

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Van

**Contacts:**

***Contact 1:***

- **Email:** drabdullahhilmi@gmail.com

- **Name:** Abdullah Hilmi Yılmaz, MD

- **Phone:** 0432 222 00 10

- **Role:** CONTACT

**Country:** Turkey

**Facility:** University of Health Science Van Training and Research Hospital

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 35286511

**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.

**PMID:** 28904521

**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.

**PMID:** 26092029

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14065

- Name: Postoperative Complications

- Relevance: HIGH

- As Found: Postoperative Complications

- ID: M9625

- Name: Hernia

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M9630

- Name: Hernia, Inguinal

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011183

- Term: Postoperative Complications

### Misc Info Module

- Version Holder: 2024-05-31
