Complication,Postoperative, İnguinal Hernia, Pain, Postoperative
Conditions
Keywords
comparision, lichtenstein mesh repair, 3-point fixation, inguinal hernia
Brief summary
This is a single-center, parallel-group randomized controlled trial conducted in 2025-2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. This study shows the comparative analysis of polypropylene conventional mesh fixation versus 3-point fixation technique to assess Post-Surgical Outcomes in Lichtenstein Hernia Repair
Detailed description
This randomized controlled trial is designed to compare the outcomes of conventional mesh fixation versus 3-point fixation in patients undergoing Lichtenstein inguinal hernia repair. The primary focus is to evaluate immediate postoperative outcomes-pain, seroma, hematoma, and wound infection-on postoperative days 1 and 7. Long-term outcomes, including recurrence and chronic groin pain, will be assessed at 3 months and 6 months. The study will include 64 patients aged 18-70 years, meeting ASA I-II criteria, and presenting with unilateral inguinal hernia. They will be randomly assigned to one of the two fixation techniques under a single-blind design where only the patient is blinded. Data will be collected using a structured proforma capturing demographics, perioperative findings, and postoperative follow-up information. Pain will be measured using the Visual Analog Scale (VAS) with standardized analgesia. Data analysis will be performed using SPSS, with appropriate statistical tests applied according to the nature of the variables. A significance level of p \< 0.05 will be used.
Interventions
PROCEDURE3-point mesh fixation
Patients in this group will undergo Lichtenstein hernia repair with polypropylene mesh fixed at three key points only (pubic tubercle, inguinal ligament and conjoint tendon). The fixation points will be strategically chosen to provide sufficient stability while minimizing tissue trauma. Rationale: Reducing the number of fixation points is expected to decrease the risk of nerve entrapment, muscle irritation, and post-operative pain, without compromising mesh position or increasing recurrence rates
PROCEDUREConventional Mesh Fixation
Patients in this group will undergo Lichtenstein tension-free hernia repair using a polypropylene mesh secured with the conventional technique. Multiple non-absorbable sutures will be placed across the inguinal floor to anchor the mesh between the transversalis fascia and the external oblique aponeurosis
Sponsors
Sahar Mughis
Sindh Institute of Urology and Transplantation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients presenting to the outpatient department with unilateral inguinal hernia requiring Lichtenstein repair Age between 18-70 years Both male and female ASA I-II
Exclusion criteria
Recurrent, bilateral, complicated, or incisional hernia Patients with pre-existing obstructive LUTS Chronic kidney disease (CKD), patients on hemodyalysis. Chronic liver disease (CLD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute post operative pain | 7 days | Acute Postoperative pain measured using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Standard analgesia (ketorolac 30 mg twice daily) will be provided. |
| wound infection | 7- 14 days | Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site |
| Seroma | 7-14 days | The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed. |
| hematoma | 7 days | A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic groin pain | 6 months | Pain persisting beyond three months post-surgery, measured using VAS and patient-reported impact on daily activities. Severity categorized as mild, moderate, or severe. |
| Hernia recurrence | 6 months | Recurrence of previously repaired inguinal sweling/hernia clinically diagnosed by physical examination and confirmed with ultrasound. |
Countries
Pakistan
Outcome results
None listed