Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

Not Applicable

• Conditions: Postoperative Ileus
• Interventions: Procedure: Electroacupuncture

• Registration Number: NCT01844908
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-24
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	Electroacupuncture	-

Primary Outcome Measures

Name	Time	Method
Incidence of prolonged ileus	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.

Secondary Outcome Measures

Name	Time	Method
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	From 0 which implies no pain at all, to 10 which implies the worst pain imaginable
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

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong SAR, China