Clinical trial NCT01844908: Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery
Official title: Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of prolonged ileus
timeFrame: Up to 1 month
Secondary outcomes:
measure: Time of first passing flatus reported by the patients
timeFrame: Up to 1 month
measure: Time to first defecation
timeFrame: Up to 1 month
measure: Time that the patients tolerated solid diet
timeFrame: Up to 1 month
measure: Duration of hospital stay
timeFrame: Up to 1 month
measure: Pain scores on visual analog scale
timeFrame: Up to 3 days
measure: Postoperative analgesic requirement
timeFrame: Up to 1 month
measure: Overall complication rate
timeFrame: Up to 1 month
measure: 30-day mortality rate
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: