Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery
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ClinicalTrials.gov Identifier: NCT01844908
Verified February 2014 by Simon S. M. Ng, Chinese University of Hong Kong. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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