Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of prolonged ileus
研究概览
简要总结
Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery. The investigators previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic resection of colonic and upper rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex cases are more likely to develop prolonged ileus and morbidity after surgery, and it is uncertain whether EA will be beneficial to them. The investigators therefore propose to conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative day 1 till day 4. These patients will be compared with a matched historical control group (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. Secondary outcomes include time to defecation and duration of hospital stay. Results of this study will help clarify the efficacy of EA in preventing prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a larger randomized controlled trial.
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
- 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 (aged between 18 and 80) with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion
- •Patients with American Society of Anesthesiologists grading I-III
- •Informed consent available
排除标准
- •Patients undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases
- •Patients undergoing laparoscopic resection of rectal cancer with en-bloc resection of surrounding organs
- •Patients who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion
- •Patients with intestinal obstruction
- •Patients with previous history of abdominal surgery
- •Patients with evidence of peritoneal carcinomatosis
- •Patients who are expected to receive epidural anesthesia or analgesia
- •Patients with cardiac pacemaker
- •Patients who are pregnant
- •Patients who are allergic to acupuncture needles
结局指标
主要结局
Incidence of prolonged ileus
时间窗: Up to 1 month
Defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support.
次要结局
- Time of first passing flatus reported by the patients(Up to 1 month)
- Time that the patients tolerated solid diet(Up to 1 month)
- Pain scores on visual analog scale(Up to 3 days)
- Postoperative analgesic requirement(Up to 1 month)
- Overall complication rate(Up to 1 month)
- Time to first defecation(Up to 1 month)
- Duration of hospital stay(Up to 1 month)
- 30-day mortality rate(Up to 1 month)
研究者
Simon S. M. Ng
Professor
Chinese University of Hong Kong
