"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer: Discharge After the First Flatus? A Prospective, Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 765
- 主要终点
- Mortality
研究概览
简要总结
Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications.
Objective. Aim of this study is to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first flatus has passed and in the absence of complication-related symptoms.
Design & Settings. Non-inferiority, open-label, single center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.
Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S.
Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality, along with surgical complications, re-operation and readmission rate were recorded and compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission and re-operation rate.
Limitations. It is a single center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non compliance" may be considered arbitrary.
详细描述
From January 2008 to September 2015, 765 patients were prospectively randomized for early discharge after laparoscopic colectomy according to E.R.A.S. programs: after obtained informed consent, 384 patients were randomly assigned to the "Ultra" E.R.A.S. group and 381 to Classic E.R.A.S. group.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable colonic cancer
排除标准
- •metastatic patients
- •T4b tumors
- •urgent operations (because of obstruction, perforation or bleeding refractory to conservative treatment)
- •huge neoplasms (>7cm)
- •positive cytology in peritoneal lavage or frank carcinosis
- •inability to tolerate pneumoperitoneum
- •ASA class 4
- •severe portal hypertension with hepato-caval gradient >10mmHg
结局指标
主要结局
Mortality
时间窗: 90 days
次要结局
- Morbidity(90 days)
- Reoperation rate(90 days)
- Readmission rate(90 days)
研究者
Luca Maria Siani
MD - Ph.D.
AUSL Romagna Rimini
