A Comparative Analysis of Polypropylene Conventional Mesh Fixation Versus 3-point Fixation Technique to Assess Post-Surgical Outcomes in Lichtenstein Hernia Repair (RCT).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sahar Mughis
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Acute post operative pain
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Recurrent, bilateral, complicated, or incisional hernia Patients with pre-existing obstructive LUTS Chronic kidney disease (CKD), patients on hemodyalysis. Chronic liver disease (CLD)
研究组 & 干预措施
Conventional Mesh Fixation Group (Standard Fixation
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)
干预措施: Conventional Mesh Fixation (Procedure)
3-Point Mesh Fixation Group (Minimal Fixation)
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)
干预措施: 3-point mesh fixation (Procedure)
结局指标
主要结局
Acute post operative pain
时间窗: 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.
hematoma
时间窗: 7 days
A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention.
wound infection
时间窗: 7- 14 days
Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site
Seroma
时间窗: 7-14 days
The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed.
次要结局
- Hernia recurrence(6 months)
- Chronic groin pain(6 months)
研究者
Sahar Mughis
Postgraduate Trainee
Sindh Institute of Urology and Transplantation