COMPARISON OF CHANGE IN QUALITY OF LIFE BETWEEN ROBOTIC AND LAPAROSCOPIC TAPP IN INGUINAL HERNIA; A NON - INFERIORITY RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in quality of life – assessed using the EuraHS-QoL score at preoperative period,24hours, 7days, 1
研究概览
简要总结
The study titled "Comparison of Change in Quality of Life Between Robotic and Laparoscopic TAPP in Inguinal Hernia: A Non-Inferiority Randomised Controlled Trial" is a single-centre, single-blinded, prospective randomized controlled trial being conducted at AIIMS, New Delhi. It aims to evaluate whether robotic TAPP is non-inferior to laparoscopic TAPP in terms of postoperative quality of life, using the EURAHS-QoL score. A total of 38 patients with primary unilateral or bilateral inguinal hernia, aged between 18 and 70 years, will be enrolled and randomized into two groups. The primary outcome is the change in quality of life at 24 hours, 7 days, 1 month, and 3 months postoperatively. Secondary outcomes include operative time, postoperative complications, recurrence, hospital stay, chronic inguinodynia, as well as surgeon satisfaction (Likert scale) and workload (SURG-TLX score). The sample size was calculated to detect a 1-unit non-inferiority margin in QoL score with 90% power and 5% significance. All surgeries will be conducted using standardized techniques by trained surgeons, and no additional financial burden will be placed on participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients will be included between 18 years and 70 years of age.
- •All primary unilateral and bilateral inguinal hernia patients.
- •Patients consenting to participate in the study after being explained about the procedure and its associated complications and outcomes.
排除标准
- •Recurrent hernia patients.
- •Patients with presence of any other hernia.
- •Patients deemed unfit for Anesthesia.
- •Patients with previous history of lower midline abdominal surgery.
结局指标
主要结局
Change in quality of life – assessed using the EuraHS-QoL score at preoperative period,24hours, 7days, 1
时间窗: 0hour, 24hours, 7days, 1 | month and 3 months
month and 3 months
时间窗: 0hour, 24hours, 7days, 1 | month and 3 months
次要结局
- Postoperative Pain – assessed using the Visual Analog Scale (VAS) at: 24 hours, 7(days, 1 month, 3 months postoperatively)
研究者
Dr Rajinder Parshad
All India Institute of Medical Sciences, New Delhi
