Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

Postoperative Ileus Clinical Trial

Official title:

Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01844908
• Other study ID #: CRE-2013.032
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2013
• Last updated: February 10, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Chinese University of Hong Kong
• Contact: Simon SM Ng, MD
• Phone: (852)26321495
• Email: simonng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Procedure:
• Electroacupuncture

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time of first passing flatus reported by the patients		Up to 1 month	No
Secondary	Time to first defecation		Up to 1 month	No
Secondary	Time that the patients tolerated solid diet		Up to 1 month	No
Secondary	Duration of hospital stay		Up to 1 month	No
Secondary	Pain scores on visual analog scale	From 0 which implies no pain at all, to 10 which implies the worst pain imaginable	Up to 3 days	No
Secondary	Postoperative analgesic requirement		Up to 1 month	No
Secondary	Overall complication rate		Up to 1 month	Yes
Secondary	30-day mortality rate		Up to 1 month	Yes