ERAS 2.0 - Accelerated 23-hour ERAS Care for Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery.
研究概览
简要总结
Rationale: Throughout the years, there has been a rapid change in the perioperative protocols and procedures surrounding colorectal surgery. Upon the introduction of the Enhanced Recovery After Surgery (ERAS) program in Western countries, an improvement in postoperative outcomes was seen. Nowadays, researchers focus on further improving the current standard ERAS programs enabling an accelerated version hereof.
Objective: The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated ERAS protocol (ERAS 2.0) for patients undergoing colorectal surgery compared to a retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after surgery.
Study design: This study is an investigator-initiated, single-center prospective study.
Study population: Patients aged ≥ 18 years ≤ 80 undergoing surgical resection for colorectal pathology that meet the eligibility criteria will be invited to participate in this study.
Intervention: Adhering to a strict multidisciplinary and multifaceted ERAS 2.0 protocol, patients receiving elective colorectal surgery will be discharged 23-hours after surgery.
Main study parameters/endpoints: Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery. Success rate will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b). Success rate (feasibility) will also be measured in percentage of patients who were not able to be discharged 23 hours after surgery.
详细描述
The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated ERAS 2.0 protocol for patients undergoing colorectal surgery compared to a retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after surgery.
Primary Objective:
To assess the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing colorectal surgery.
Secondary Objective(s):
- Postoperative outcomes, including morbidity and mortality within 30 days;
- Patient experience and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Is ≥ 18 years ≤ 80;
- •BMI ≤ 35 kg/m2;
- •WHO performance status = 0
- •Is diagnosed with (non-complicated) colorectal cancer
- •Is scheduled to undergo elective laparoscopic colorectal surgery (ileocecal resection, right or left hemicolectomy, transvers colon resection) with primary anastomosis;
- •Primary anastomosis is performed intracorporeally;
- •Uncomplicated operation;
- •Readily available ambulant care provided by an adult family member for the first 24 hours after discharge;
- •Patient is adequately reachable by phone.
排除标准
- •ASA classification ≥ 3;
- •Subjects who have limited mobility and/or need to be aided/assisted when mobilizing;
- •Subjects with a history of active pulmonary infection, any other active infection, any uncontrolled medical disease
- •Subjects with a contraindication for oral NSAIDs;
- •Subjects with a contraindication for spinal anesthesia;
- •Subjects requiring parenteral nutrition prior to surgery;
- •Subjects scheduled to undergo lower rectal resections;
- •Subjects receiving an ostomy;
- •Subjects who experience complications preoperatively;
- •Subjects who are mentally incompetent, challenged or requiring aid with daily life activities.
结局指标
主要结局
Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery.
时间窗: 30 days
Success rate (feasibility) will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b).
次要结局
- • Number of Participants who develop Postoperative Complications within 30 days(30 day)
- • Number of Participants with Postoperative Mortality within 30 days(30 days)
- • Patient satisfaction evaluation by means of a questionnaire to evaluate the patients subjective experience during the duration of this study.(10 days)