Status
Conditions
Treatments
About
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.
Full 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 (Table 1) . 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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal