Impact of Enhanced Recovery (ERAS) Protocol After Laparoscopic Colorectal Surgery Implementation on Clinical Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
The study will assess the impact on quality of care after implementation of the ERAS (Enhanced Recovery After Surgery) protocol for laparoscopic colorectal surgery in Vilnius University Hospital Santaros klinikos. The primary goal of this study is to compare efficacy of two different types of anaesthesia - general and combined (spinal and general), efficacy of multimodal analgesia in both groups, need for rescue analgetics, time to bowel movement, time to ambulation. We also aim to study overall patient satisfaction and measure health-related quality of life, from date of randomisation until the date of hospital discharge, 30 days, 3 months and 6 months post-discharge.
详细描述
Recovery After Surgery (ERAS) protocol is a multimodal perioperative care pathway designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery, now widely accepted in laparoscopic colorectal surgery.
In laparoscopic colorectal surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia and hypotension, prevention of volume overload, preference for minimally invasive surgery, multimodal analgesia with reduced opioid requirements, local anaesthetics for wound infiltration, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early postoperative feeding, to promote rapid recovery of gastrointestinal functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older.
- •scheduled for laparoscopic colorectal surgery.
- •patient informed and having accepted the principle of enhanced recovery after surgery.
- •patient written consent will be obtained preoperatively for eligible study participants.
排除标准
- •Preoperative:
- •patients who can not comply with the ERAS protocol because they do not understand the language or has a cognitive disorder.
- •patients with a documented allergy to nonsteroidal anti-inflammatory drugs and acetaminophen.
- •preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis.
- •patients with a history of hepatic impairment.
- •chronic pain condition that required daily opioid dependence.
- •conversion to laparotomy.
结局指标
主要结局
Postoperative pain intensity
时间窗: From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.
Number of patients with unsatisfactory pain relief evaluated with visual analogic scale (VAS \> 4, with 0-no pain, 10-worst possible pain)
次要结局
- Total post-operative analgetics consumption(From time to PACU admission until 72 hours postoperatively)
- Time to bowel movement(From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.)
- Time oral intake(From time of PACU admission until the date of first documented liquid oral intake.)
- Time to ambulation(From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.)
- Time to urinary catheter removal(From time of PACU admission until the date of urinary catheter removed will be measured.)
- Time to hospital discharge(From the date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.)
- Post-operative nausea and vomiting(Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.)
- Post-operative pruritus(From time to PACU admission until 72 hours postoperatively.)
- Patient satisfaction(From time to PACU admission until discharge, every 6 hours for the first 24-hour, then every 12 hours until 72 hours.)
- Incidence of surgical complications(From date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.)
- Readmission to the hospital(From the date of randomisation until 30 days postoperatively.)
- A measure of health status with EQ-5D-5L instrument(From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.)
研究者
Egle Kontrimaviciute
MD, PhD, Assoc Prof
Vilnius University