Implementation of the Early Recovery After Surgery (ERAS) Protocol in Colorectal Cancer Patients: a Phase II Multi-Center, Prospective Single Arm Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Postoperative time to discharge criteria
研究概览
简要总结
The goal of this study is to implement and investigate the efficacy of an Early Recovery After Surgery (ERAS) protocol in South Korean colorectal cancer patients.
The primary outcome will be the postoperative time taken to achieve the 'discharge criteria'.
Secondary outcomes will include adherence, hospital stay, early complications, mortality, pain scores, re-admission and quality of life questionnaire scores.
As a single arm study, all participants will be treated according to an ERAS protocol, which includes components such as early ambulation, minimal fasting, multimodal pain control and omission of- or early removal of invasive catheters.
详细描述
This multi-center prospective single arm clinical trial aims to investigate each component and item in the ERAS protocol implemented to perioperative care of colorectal cancer patients.
The primary endpoint will be the 'postoperative time to discharge criteria'. Discharge criteria will be defined as meeting all the criteria below:
- No fever
- Eating more than half of given solid diet
- No nausea or vomiting
- Gas passing or defecation
- Able to walk (more than 1 hour a day)
- No sign of surgical site infection
- Adequate pain control with oral analgesics such as acetaminophen and NSAIDs
- No sign of any other complication
Secondary outcomes will include:
- adherence of each ERAS item within the protocol
- postoperative hospital stay
- early postoperative complications (within 30 days of surgery)
- postoperative mortality
- postoperative pain scores (VAS scores)
- re-admission within 30 days of surgery
- Quality of Recovery questionnaire
- Health-related quality of life questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above the age of 19 years
- •Pathologic diagnosis of colon cancer or rectal cancer
- •Scheduled for minimally invasive (laparoscopic or robotic) colorectal cancer surgery
- •Agreed to participate after a detailed explanation of the study
排除标准
- •Stage 4 (distant metastasis)
- •Emergency surgery
- •Scheduled for transanal surgery
- •Perforated colorectal cancer
- •Obstructed colorectal cancer
- •Familial colorectal cancer (HNPCC, FAP, MUYH polyposis, Peutz-Jeghers syndrome)
- •Previous treatment for colorectal cancer
- •History of other cancer within 5 years (excluding skin cancer)
- •Acute infection
- •Unable to read or understand the study
- •Mental impairment
研究组 & 干预措施
ERAS implemented arm
ERAS protocol implemented patients (single arm).
干预措施: ERAS protocol (Procedure)
结局指标
主要结局
Postoperative time to discharge criteria
时间窗: From the date of surgery until the date of first achieving all of the discharge criteria, assessed up to 100 days
The time (days) from initiation of surgery to achieving the discharge criteria. Discharge criteria is defined as meeting all of the following criteria: * No fever * Eating more than half of given solid diet * No nausea or vomiting * Gas passing or defecation * Able to walk (more than 1 hour a day) * No sign of surgical site infection * Adequate pain control with oral analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) * No sign of any other complication
次要结局
- Adherence to the ERAS protocol(From date of enrollment to the date of discharge after surgery, assessed up to 100 days)
- Hospital stay(From the date of hospital admission until the date of discharge after surgery, assessed up to 100 days)
- Early postoperative complication(From the day of surgery to the 30th postoperative day)
- Postoperative mortality(From day of surgery until the end of clinical data gathering, assessed upto 100 days.)
- Postoperative pain score: the Numeric Rating Scale (NRS)(From day of surgery until the end of clinical data gathering, assessed upto 100 days.)
- Re-admission within 30 days(From randomization until the end of clinical data gathering, assessed upto 100 days.)
- Health-related Quality of Life(From randomization until the end of clinical data gathering, assessed upto 100 days.)