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| Name | Class |
|---|---|
| Sindh Institute of Urology and Transplantation | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Mesh Fixation Group (Standard Fixation | Active Comparator | Lichtenstein inguinal hernia repair with polypropylene mesh fixed using the conventional technique (multiple non-absorbable sutures across the inguinal floor) to measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up) |
|
| 3-Point Mesh Fixation Group (Minimal Fixation) | Experimental | Lichtenstein inguinal hernia repair with polypropylene mesh fixed at only three strategic points to minimize tissue trauma. To measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-point mesh fixation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute post operative pain | 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. | 7 days |
| wound infection | Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site | 7- 14 days |
| Seroma | The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed. | 7-14 days |
| hematoma | A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic groin pain | Pain persisting beyond three months post-surgery, measured using VAS and patient-reported impact on daily activities. Severity categorized as mild, moderate, or severe. | 6 months |
| Hernia recurrence |
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sindh Institute of Urology and Transplantation | Karachi | Sindh | 74200 | Pakistan |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D011183 | Postoperative Complications |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional Mesh Fixation | Procedure | 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 |
|
Recurrence of previously repaired inguinal sweling/hernia clinically diagnosed by physical examination and confirmed with ultrasound.
| 6 months |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |