A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Time to defecation
研究概览
简要总结
Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou 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' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Design: Prospective, randomized, noninferiority trial.
Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.
Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.
Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.
Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.
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 80 Years（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
- •Age of patients between 18 and 80 years
- •Patients with American Society of Anesthesiologists (ASA) grading I-II
- •Patients with no severe physical disability
- •Patients 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
- •Patients with planned stoma creation
- •Patients undergoing emergency surgery
- •Patients with evidence of peritoneal carcinomatosis
- •Patients with previous history of midline laparotomy
- •Patients who are expected to receive epidural opioids for postoperative pain management
- •Patients with cardiac pacemaker
- •Patients 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
- Total postoperative hospital stay(Up to 1 month)
- Time of first passing flatus reported by the patients(Up to 1 month)
- Time that the patients tolerated solid diet(Up to 1 month)
- Time to walk independently(Up to 1 month)
- Pain scores on visual analog scale(Up to 1 month)
- Morbidity(Up to 1 month)
- Mortality(Up to 1 month)
- Readmission rate(Up to 1 month)
- Quality of life(Up to 1 month)
研究者
Simon S. M. Ng
Professor of Surgery
Chinese University of Hong Kong