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).
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
- Conditions the study is for
- Inguinal Hernia Unilateral, Postoperative Pain, Mesh
- 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
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.
- Conditions
- Inguinal Hernia Unilateral, Postoperative Pain, Mesh
- 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 group | Role | What they receive |
|---|---|---|
| Tacker Fixation | Experimental | Absorbable tacker mesh fixation Receives: Procedure: Absorbable Tacker Fixation |
| No Fixation | Active comparator | Non-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.
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)
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
Postoperative Hematoma and Seroma Formation
Occurrence of postoperative hematoma and seroma was evaluated clinically during follow-up.
Measured: Within 30 postoperative days
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.
- First posted26 May 2026
- Study start1 Jan 2022
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Onur I Dinçer, MD, Principal investigator, General Surgery Department, Medical Park Antalya Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07605377
- Acronym / sponsor ID
- HERNOFIX / 2022- 308
- Conditions
- Inguinal Hernia Unilateral, Postoperative Pain, Mesh
- Keywords
- Laparoscopic Inguinal Hernia Repair, Totally Extraperitoneal Inguinal Hernia Repair, Mesh Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacker Fixation | Experimental | Procedure: Absorbable Tacker FixationAbsorbable tacker mesh fixation |
| No Fixation | Active comparator | Procedure: Non-fixation Mesh PlacementNon-fixation mesh placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Recurrent inguinal hernia
- Bilateral inguinal hernia
- Incarcerated or strangulated hernia
- Previous lower abdominal surgery
- Patients with missing clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable Tacker FixationMesh fixation was performed using absorbable tackers during totally extraperitoneal laparoscopic inguinal hernia repair. | Procedure or surgery | Tacker Fixation |
| Non-fixation Mesh PlacementMesh was placed without fixation during totally extraperitoneal laparoscopic inguinal hernia repair. | Procedure or surgery | No Fixation |
Primary outcome
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.
3 secondary outcomes
Quality of Life Assessment
Time frame: Postoperative 6 months and 12 months
Postoperative Hematoma and Seroma Formation
Time frame: Within 30 postoperative days
Hernia Recurrence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur I Dinçer, MD principal investigator
General Surgery Department, Medical Park Antalya Hospital
1 site in 1 country: see every site and its status.
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.