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OpenTrials
Completed

NCT Number: NCT07605377

Tacker Fixation and Pain After TEP Repair

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Absorbable Tacker Fixation

Procedure

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

Non-fixation Mesh Placement

Procedure

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

Primary outcomes

  1. Postoperative Pain Scores

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

    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.

Secondary outcomes

  1. Quality of Life Assessment

    Time frame: Postoperative 6 months and 12 months

    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).

  2. Postoperative Hematoma and Seroma Formation

    Time frame: Within 30 postoperative days

    Occurrence of postoperative hematoma and seroma was evaluated clinically during follow-up.

  3. Hernia Recurrence

    Time frame: 12 months

    Hernia recurrence was assessed during postoperative follow-up visits.

Sponsors and collaborators

Lead sponsor

Antalya Health Sciences University

Other

Registry information

Official study title

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

Acronym: HERNOFIX

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 26, 2026
Registry last updated
Jun 1, 2026

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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