Tacker Fixation and Pain After TEP Repair

NCT07605377 | Completed

• 1 other identifier: 2022- 308
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The role of mesh fixation in laparoscopic totally extraperitoneal (TEP) inguinal hernia repair remains controversial. While fixation may increase postoperative pain, concerns about recurrence in larger defects prevent its complete abandonment. This study aimed to compare absorbable tacker fixation with non-fixation in terms of postoperative pain, quality of life, and recurrence.

Conditions

Inguinal Hernia Unilateral; Postoperative Pain; Mesh

Keywords

Laparoscopic Inguinal Hernia Repair; Totally Extraperitoneal Inguinal Hernia Repair; Mesh Fixation

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores

  Postoperative pain was evaluated using the Visual Analog Scale (VAS; 0-10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain) at predefined postoperative time points.

  Postoperative 8 hours, 24 hours, and postoperative day 10, 6th months and 12th months

Secondary Outcomes (3)

• Quality of Life Assessment

  Postoperative 6 months and 12 months

• Postoperative Hematoma and Seroma Formation

  Within 30 postoperative days

• Hernia Recurrence

  12 months

Study Arms (2)

Tacker Fixation

EXPERIMENTAL

Absorbable tacker mesh fixation

Procedure: Absorbable Tacker Fixation

No Fixation

ACTIVE COMPARATOR

Non-fixation mesh placement

Procedure: Non-fixation Mesh Placement

Interventions

Absorbable Tacker Fixation PROCEDURE

Mesh fixation was performed using absorbable tackers during totally extraperitoneal laparoscopic inguinal hernia repair.

Tacker Fixation

Non-fixation Mesh Placement PROCEDURE

Mesh was placed without fixation during totally extraperitoneal laparoscopic inguinal hernia repair.

No Fixation

Eligibility Criteria

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

You may qualify if:

• Adult patients aged 18-65 years
• Patients diagnosed with primary unilateral inguinal hernia
• Patients who underwent totally extraperitoneal laparoscopic inguinal hernia repair
• Availability of complete perioperative and follow-up data

You may not qualify if:

• Recurrent inguinal hernia
• Bilateral inguinal hernia
• Incarcerated or strangulated hernia
• Previous lower abdominal surgery
• Patients with missing clinical data
• Patients lost to follow-up

Sponsors & Collaborators

• Antalya Health Sciences University: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Onur I Dinçer, MD

  General Surgery Department, Medical Park Antalya Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)