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Tacker Fixation and Pain After TEP Repair

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07605377
Acronym
HERNOFIX
Enrollment
60
Registered
2026-05-26
Start date
2022-01-01
Completion date
2025-01-01
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia Unilateral, Mesh, Postoperative Pain

Keywords

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

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.

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.

Interventions

PROCEDUREAbsorbable Tacker Fixation

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

PROCEDURENon-fixation Mesh Placement

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

Sponsors

Antalya Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain ScoresPostoperative 8 hours, 24 hours, and postoperative day 10, 6th months and 12th monthsPostoperative 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

MeasureTime frameDescription
Quality of Life AssessmentPostoperative 6 months and 12 monthsQuality 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 Hematoma and Seroma FormationWithin 30 postoperative daysOccurrence of postoperative hematoma and seroma was evaluated clinically during follow-up.
Hernia Recurrence12 monthsHernia recurrence was assessed during postoperative follow-up visits.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOROnur I Dinçer, MD

General Surgery Department, Medical Park Antalya Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026