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Inguinal Hernia UnilateralHERNOFIXNCT07605377

Tacker Fixation and Pain After TEP Repair

A study testing Absorbable Tacker Fixation and Non-fixation Mesh Placement in people with Inguinal Hernia Unilateral and Postoperative Pain, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Absorbable Tacker Fixation and Non-fixation Mesh Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2022to 1 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Antalya Training and Research Hospital

    Antalya, Antalya, 07100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Absorbable Tacker Fixation, Non-fixation Mesh Placement
Keywords
Laparoscopic Inguinal Hernia Repair, Totally Extraperitoneal Inguinal Hernia Repair, Mesh Fixation
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Absorbable Tacker FixationProcedure or surgery

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

  • Non-fixation Mesh PlacementProcedure or surgery

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

Study groups in NCT07605377
Study groupRoleWhat they receive
Tacker FixationExperimentalAbsorbable tacker mesh fixation
Receives: Procedure: Absorbable Tacker Fixation
No FixationActive comparatorNon-fixation mesh placement
Receives: Procedure: Non-fixation Mesh Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. 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).

    Measured: Postoperative 6 months and 12 months

  2. Postoperative Hematoma and Seroma Formation

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

    Measured: Within 30 postoperative days

  3. Hernia Recurrence

    Hernia recurrence was assessed during postoperative follow-up visits.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2024
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07605377
Sponsor's protocol ID
2022- 308
Acronym
HERNOFIX
Status last verified
May 2026
First submitted
19 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Absorbable Tacker Fixation and Non-fixation Mesh Placement in people with Inguinal Hernia Unilateral and Postoperative Pain, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Scores (time frame: Postoperative 8 hours, 24 hours, and postoperative day 10, 6th months and 12th months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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