ROBOTIC VERSUS LAPAROSCOPIC TRANS ABDOMINAL PRE-PERITONEAL REPAIR OF BILATERAL INGUINAL HERNIA : A RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare postoperative pain at 24 hours, 7 days, 1 month, 3 months and one year
研究概览
简要总结
Inguinal hernia repair is one of the most frequently performed surgical procedures globally,
accounting for over 20 million operations annually¹. The condition has a lifetime risk of
approximately 27% in men and 3% in women², making it a substantial contributor to surgical
workloads worldwide. Among these cases, bilateral inguinal hernias form a significant
subset, comprising up to 20–25% of all inguinal hernia presentations³. These cases are
inherently more complex, requiring bilateral dissection, longer operative times, and greater
attention to anatomical precision—particularly to avoid complications such as chronic groin
pain or recurrence.
Given these considerations, there is a pressing need for a prospective, study comparing both
economic and clinical outcomes between R-TAPP and L-TAPP in bilateral hernia repair. The
present study aims to address this by assessingpostoperative pain direct and indirect costs
andhernia recurrence using standardized methods in a tertiary care setting in India. By
generating data that integrates cost analysis with patient outcomes, this study will provide
valuable insights to inform surgical choice, guide institutional planning, and promote
evidence-based, cost-conscious healthcare delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patients aged from 18 to 65 years.
- •2 Diagnosed with bilateral inguinal hernia (direct, indirect, or mixed) planned for elective minimally invasive repair.
- •3 ASA physical status I and II 4 Willingness to undergo either robotic or laparoscopic TAPP repair as per allocation.
排除标准
- •Unilateral inguinal hernia.
- •Complicated hernias (for example obstructed, strangulated, incarcerated).
- •Inability or unwillingness to comply with follow up schedule.
- •Patients having any infectious or inflammatory disease condition pre-operatively .
- •Patient on chronic analgesic use
- •Concomitant malignancy.
结局指标
主要结局
To compare postoperative pain at 24 hours, 7 days, 1 month, 3 months and one year
时间窗: To compare postoperative pain at 24 hours, 7 days, 1 month, 3 months and one year | following surgery measured using the Visual Analog Scale (VAS)
following surgery measured using the Visual Analog Scale (VAS)
时间窗: To compare postoperative pain at 24 hours, 7 days, 1 month, 3 months and one year | following surgery measured using the Visual Analog Scale (VAS)
次要结局
- To compare inflammatory stress response as measured by Serum CRP levels
- To compare operative duration: Measured from skin incision to skin closure (in(minutes).)
- To compare cost effectiveness(Intraop and followup at 3 m and 1 year)
- To compare quality of life(at 3 months and one year following surgery)
- To compare recurrence(at 3 months and one year following surgery)
研究者
Nishant Ranjan
all india institute of medical sciences