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临床试验/NCT01844908
NCT01844908Unknown不适用

Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon S. M. Ng

Professor

Chinese University of Hong Kong

研究点 (1)

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