Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

NCT ID: NCT01844908

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-05-31

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.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electroacupuncture

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: PROCEDURE

Interventions

Electroacupuncture

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon S. M. Ng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon SM Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong SAR, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Simon SM Ng, MD

Role: CONTACT

simonng@surgery.cuhk.edu.hk

(852)26321495

Wing Wa Leung, MSc

Role: CONTACT

leungww@surgery.cuhk.edu.hk

(852)26321495

Facility Contacts

Simon SM Ng, MD

Role: primary

simonng@surgery.cuhk.edu.hk

(852)26321495

Wing Wa Leung, MSc

Role: backup

leungww@surgery.cuhk.edu.hk

(852)26321495

Other Identifiers

CRE-2013.032

Identifier Type: -

Identifier Source: org_study_id