Tacker Fixation and Pain After TEP Repair (HERNOFIX)

Absorbable Tacker Fixation Versus Non-Fixation in Totally Extraperitoneal Inguinal Hernia Repair: A Prospective Randomized Study on Postoperative Pain and Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Mesh; Inguinal Hernia Unilateral
• Intervention / Treatment: Procedure: Absorbable Tacker Fixation; Procedure: Non-fixation Mesh Placement

Detailed Description

Eligible patients were adults aged 18-65 years, classified as ASA 1-2, who presented with symptomatic unilateral inguinal hernia and were scheduled for totally extraperitoneal (TEP) repair. Patients were randomly allocated to either the tacker or non-fixation group. Patients were randomized in a 1:1 ratio using a computer-generated randomization sequence. Allocation concealment was ensured using sequentially numbered, sealed, opaque envelopes prepared by a researcher not involved in patient recruitment or outcome assessment. Group assignment was revealed intraoperatively after confirmation of eligibility. All randomized patients were included in the final analysis according to the intention-to-treat principle. There were no losses to follow-up, and all patients completed the scheduled postoperative assessments.

Exclusion criteria included ASA 3-4 status, age <18 or >65 years, refusal to participate, bilateral or recurrent hernia, concomitant abdominal surgery (e.g., cholecystectomy, umbilical hernia repair), contraindication to general anesthesia, and preference for open or transabdominal pre-peritoneal (TAPP) repair.

All patients underwent a standard TEP inguinal hernia repair under general anesthesia. A 15×15 cm polypropylene mesh was used in all cases. In the tacker group, the mesh was fixed using absorbable tackers, whereas in the no-tacker group, the mesh was placed without fixation. Tacker fixation was performed in a standardized manner at three predefined anatomical sites: the Cooper ligament; the most craniomedial aspect of the mesh (posterior to the rectus muscle); and the most craniolateral aspect of the mesh, located approximately 2 cm craniomedial to the anterior superior iliac spine. A standardized postoperative analgesic protocol was applied to all patients. At the time of emergence from anesthesia, all patients received intravenous paracetamol (500 mg) and tramadol (50 mg) as part of the standardized postoperative analgesic protocol. Postoperative analgesic requirement was evaluated using the visual analogue scale (VAS). All patients received a standardized analgesic regimen; however, additional (rescue) analgesia was administered when VAS scores reached ≥4, corresponding to moderate pain as defined in the literature.

Demographic and clinical data collected included sex, age, body mass index (BMI), ASA score, hernia laterality, Nyhus classification, hernia localization (indirect, direct, or femoral), operative time, defect size, tacker fixation status and occurrence of peritoneal tear. Postoperative outcomes measured were analgesic consumption until discharge, VAS scores at 8 hours, 24 hours, and 10th postoperative day, 6th and 12th postoperative months, incidence of hematoma or seroma, time to return to normal activity, and long-term outcomes at 6 months and 1 year assessed using Eura HS quality of life scores (QoL) (pain, restriction, cosmetic). For the Eura HS QoL assessment, all data was collected via a 20-question survey conducted over the phone. Hernia recurrence was recorded, including the month of occurrence if applicable. The primary endpoints were postoperative analgesic requirement, postoperative pain scores at predefined time points, and the EuraHS quality of life (QoL) score. Secondary endpoints included postoperative hematoma, seroma formation, and recurrence rates.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Antalya
    • Antalya, Antalya, Turkey (Türkiye), 07100
      • Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacker Fixation; Absorbable tacker mesh fixation	Procedure: Absorbable Tacker Fixation; Mesh fixation was performed using absorbable tackers during totally extraperitoneal laparoscopic inguinal hernia repair.
Active Comparator: No Fixation; Non-fixation mesh placement	Procedure: Non-fixation Mesh Placement; Mesh was placed without fixation during totally extraperitoneal laparoscopic inguinal hernia repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Hematoma and Seroma Formation	Occurrence of postoperative hematoma and seroma was evaluated clinically during follow-up.	Within 30 postoperative days
Hernia Recurrence	Hernia recurrence was assessed during postoperative follow-up visits.	12 months
Quality of Life Assessment	Quality of life was assessed using the European Registry for Abdominal Wall Hernias Quality of Life questionnaire (EuraHS-QoL; score range 0-90, where higher scores indicate worse quality of life and greater symptom burden).	Postoperative 6 months and 12 months

Collaborators and Investigators

• Sponsor: Antalya Health Sciences University
• Investigators: Principal Investigator: Onur I Dinçer, MD, General Surgery Department, Medical Park Antalya Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic Inguinal Hernia Repair; Mesh Fixation; Totally Extraperitoneal Inguinal Hernia Repair
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 2022- 308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No