Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

NCT01844908 | Unknown

• 1 other identifier: CRE-2013.032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of prolonged ileus

  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.

  Up to 1 month

Secondary Outcomes (8)

• Time of first passing flatus reported by the patients

  Up to 1 month

• Time to first defecation

  Up to 1 month

• Time that the patients tolerated solid diet

  Up to 1 month

• Duration of hospital stay

  Up to 1 month

• Pain scores on visual analog scale

  Up to 3 days

Study Arms (1)

Electroacupuncture

EXPERIMENTAL

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

Electroacupuncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong SAR, China

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon SM Ng, MD

CONTACT

(852)26321495; simonng@surgery.cuhk.edu.hk

Wing Wa Leung, MSc

CONTACT

(852)26321495; leungww@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 3, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

CN (1)