Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Postoperative Ileus Clinical Trial

Official title:

A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059603
• Other study ID #: CRE-2013.009
• Status: Recruiting
• Phase: Phase 3
• First received: February 10, 2014
• Last updated: February 10, 2014
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: Chinese University of Hong Kong
• Contact: Simon S. M. Ng, MD
• Phone: (852) 2632 1495
• 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

Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.

Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.

Design: Prospective, randomized, noninferiority trial.

Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.

Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.

Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.

Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer

• Age of patients between 18 and 80 years

• Patients with American Society of Anesthesiologists (ASA) grading I-II

• Patients with no severe physical disability

• Patients who require no assistance with the activities of daily living

• Informed consent available

Exclusion Criteria:

• Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy

• Patients with planned stoma creation

• Patients undergoing emergency surgery

• Patients with evidence of peritoneal carcinomatosis

• Patients with previous history of midline laparotomy

• Patients who are expected to receive epidural opioids for postoperative pain management

• Patients with cardiac pacemaker

• Patients who are allergic to the acupuncture needles

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Procedure:
• Electroacupuncture

• Fast-track program

Locations

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

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	Time to defecation	Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.	Up to 1 month	No
Secondary	Total postoperative hospital stay	Including hospital stay of patients who are readmitted within 30 days after surgery.	Up to 1 month	No
Secondary	Time of first passing flatus reported by the patients		Up to 1 month	No
Secondary	Time that the patients tolerated solid diet		Up to 1 month	No
Secondary	Time to walk independently		Up to 1 month	No
Secondary	Pain scores on visual analog scale	From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.	Up to 1 month	No
Secondary	Morbidity		Up to 1 month	Yes
Secondary	Mortality		Up to 1 month	Yes
Secondary	Readmission rate		Up to 1 month	No
Secondary	Quality of life	Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires	Up to 1 month	No