Electroacupuncture Combined With Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to defecation
研究概览
简要总结
Background: The investigators' previous study demonstrated that electroacupuncture (EA) reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' (FT) perioperative program may help accelerate recovery after colorectal surgery. It is uncertain whether the combination of EA and FT program will result in faster recovery after laparoscopic colorectal surgery when compared with FT program alone.
Objectives: To compare the efficacy of EA combined with FT program versus FT program alone in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery
Design: Prospective randomized trial.
Subjects: 72 consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without conversion will be recruited.
Interventions: Patients will be randomly allocated to one of the two groups receiving either EA + FT program, or FT program alone.
Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time to resume diet, pain scores, analgesic requirement, morbidity, quality of life, and medical costs.
Conclusions: This study serves as a good example that illustrates an integrated approach in combining Chinese and Western models of health care. It will provide evidence-based clarification of the role of EA in enhancing recovery after laparoscopic colorectal surgery within a FT perioperative care setting. As laparoscopic colorectal surgery has been shown to have a higher direct cost than the open counterpart, a faster postoperative recovery may help reduce the financial burden to the hospital/healthcare system.
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
- Single (Outcomes Assessor)
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
- •Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer (adenocarcinoma of the colorectum of which the lowest margin of the tumor is located >12 cm from the anal verge as measured by rigid sigmoidoscopy)
- •Age of patients >18 years
- •Those with American Society of Anesthesiologists (ASA) grading I-III
- •Those with no cognitive impairment (Mini Mental State Examination score 24 out of 30)
- •Those with no severe physical disability
- •Those who require no assistance with the activities of daily living
- •Informed consent available
排除标准
- •Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy; those with planned stoma creation
- •Those undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases
- •Those undergoing laparoscopic resection of colorectal cancer with en bloc resection of surrounding organs
- •Those who developed intraoperative problems or complications that required conversion
- •Those undergoing emergency surgery
- •Those with evidence of peritoneal carcinomatosis
- •Those with previous history of midline laparotomy
- •Those who are expected to receive epidural opioids for postoperative pain management
- •Those who are pregnant
- •Those with cardiac pacemaker
- •Those with coagulopathy
- •Those who are allergic to the acupuncture needles
结局指标
主要结局
Time to defecation
时间窗: Up to 1 month
Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.
次要结局
- Readmission rate(Up to 1 month)
- Total postoperative hospital stay(Up to 1 month)
- Time to walk independently(Up to 1 month)
- Pain scores on visual analog scale(Up to 1 month)
- Time of first passing flatus reported by the patients(Up to 1 month)
- Incidence rate of adverse events related to electroacupuncture(Up to 1 month)
- Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery(Up to 1 month)
- Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery(Up to 1 month)
- Time that the patients tolerated solid diet(Up to 1 month)
- Postoperative 30-day morbidity(Up to 1 month)
- Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 2 and 4 weeks after surgery(Up to 1 month)
- Direct/indirect medical costs and out-of-hospital economic costs(Up to 1 month)
研究者
Simon S. M. Ng
Professor
Chinese University of Hong Kong