Evaluating the efficacy of enhanced recovery after surgery(eras) protocols in laparoscopic groin hernia repair-An open label prospective randomized study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. To compare postopera1ve pain
研究概览
简要总结
This thesis titled “Evaluating the Efficacy of Enhanced Recovery After Surgery (ERAS) Protocols in Laparoscopic Groin Hernia Repair: An Open Label Prospective Randomized Study” is a prospective randomized controlled trial conducted at AIIMS Deoghar. It aims to compare ERAS protocols with conventional perioperative care in 100 patients (50 per group) undergoing laparoscopic groin hernia repair (TAPP/TEP).
The ERAS group will receive preoperative counseling, carbohydrate loading, minimal fasting, optimized anesthesia, early oral intake, early mobilization, and multimodal analgesia with minimal opioid use. The conventional care group will follow standard practices including prolonged fasting, opioid-based analgesia, and delayed mobilization/feeding.
Primary outcomes: postoperative pain scores and length of hospital stay. Secondary outcomes: time to return to normal activities, complication rates, readmissions, patient satisfaction, and quality of life (EuraHS-QoL).
The study expects ERAS to reduce pain, shorten hospital stay by 4–6 hours, accelerate recovery by 2–3 days, maintain or lower complication rates, and improve overall patient satisfaction. Findings will provide evidence for integrating ERAS into routine laparoscopic groin hernia repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 aged 18 years– 70 years with unilateral or bilateral groin hernia (inguinal or femoral).
- •Planned elective laparoscopic TAPP or TEP repair.
- •American Society of Anesthesiologists (ASA) grade I or II.
- •Willing to provide informed consent.
排除标准
- •Emergency hernia repair (e.g., strangulated hernia)..
- •ASA grade III or higher.
- •Contraindications to laparoscopy (e.g., severe cardiopulmonary disease).
- •Chronic opioid use or pain syndromes.
- •Combined Procedure (e.g., Lap Cholecystectomy with TAPP/TEP)
- •Pregnant patients.
结局指标
主要结局
1. To compare postopera1ve pain
时间窗: 1.Postoperative Pain: Measured using the | Visual Analog Scale (VAS, 0–10) at 0, 6, 12, 24, and 48 hours and after 1 week, after 4 week and 12 week post-surgery | 2. Length of Hospital Stay: Time from surgery( to discharge (hours).
scores between ERAS and
时间窗: 1.Postoperative Pain: Measured using the | Visual Analog Scale (VAS, 0–10) at 0, 6, 12, 24, and 48 hours and after 1 week, after 4 week and 12 week post-surgery | 2. Length of Hospital Stay: Time from surgery( to discharge (hours).
conven1onal care groups
时间窗: 1.Postoperative Pain: Measured using the | Visual Analog Scale (VAS, 0–10) at 0, 6, 12, 24, and 48 hours and after 1 week, after 4 week and 12 week post-surgery | 2. Length of Hospital Stay: Time from surgery( to discharge (hours).
2. To assess the length of hospital stay in
时间窗: 1.Postoperative Pain: Measured using the | Visual Analog Scale (VAS, 0–10) at 0, 6, 12, 24, and 48 hours and after 1 week, after 4 week and 12 week post-surgery | 2. Length of Hospital Stay: Time from surgery( to discharge (hours).
both groups.
时间窗: 1.Postoperative Pain: Measured using the | Visual Analog Scale (VAS, 0–10) at 0, 6, 12, 24, and 48 hours and after 1 week, after 4 week and 12 week post-surgery | 2. Length of Hospital Stay: Time from surgery( to discharge (hours).
次要结局
- 1. To evaluate the time to return to normal activities/work(work, daily tasks)(2To compare complication rates (e.g., seroma, hematoma, infection, recurrence) between groups.)
研究者
DR BHAVESH JIYANI
AIIMS deoghar