Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

NCT ID: NCT04090073

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-10-31

Brief Summary

Background: The investigators' previous study demonstrated that electroacupuncture (EA) 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' (FT) perioperative program may help accelerate recovery after colorectal surgery. It is uncertain whether the combination of EA and FT program will result in faster recovery after laparoscopic colorectal surgery when compared with FT program alone.

Objectives: To compare the efficacy of EA combined with FT program versus FT program alone in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery

Design: Prospective randomized trial.

Subjects: 72 consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without conversion will be recruited.

Interventions: Patients will be randomly allocated to one of the two groups receiving either EA + FT program, or FT program alone.

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

Conclusions: This study serves as a good example that illustrates an integrated approach in combining Chinese and Western models of health care. It will provide evidence-based clarification of the role of EA in enhancing recovery after laparoscopic colorectal surgery within a FT perioperative care setting. As laparoscopic colorectal surgery has been shown to have a higher direct cost than the open counterpart, a faster postoperative recovery may help reduce the financial burden to the hospital/healthcare system.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Electroacupuncture Plus Fast-track Perioperative Program

Patients who are randomized to the intervention arm will receive Electroacupuncture combined with Fast-track program. Each session of Electroacupuncture will last for 20 minutes. The patients will undergo one session of Electroacupuncture daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: PROCEDURE

As above

Fast-track Perioperative program

Intervention Type: OTHER

As above

Fast-track Perioperative Program

Patients who are randomized to the control arm will receive Fast-track program alone.

Group Type: ACTIVE_COMPARATOR

Fast-track Perioperative program

Intervention Type: OTHER

As above

Interventions

Electroacupuncture

As above

Intervention Type: PROCEDURE

Fast-track Perioperative program

As above

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer (adenocarcinoma of the colorectum of which the lowest margin of the tumor is located >12 cm from the anal verge as measured by rigid sigmoidoscopy)
• Age of patients >18 years
• Those with American Society of Anesthesiologists (ASA) grading I-III
• Those with no cognitive impairment (Mini Mental State Examination score 24 out of 30)
• Those with no severe physical disability
• Those 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; those with planned stoma creation
• Those undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases
• Those undergoing laparoscopic resection of colorectal cancer with en bloc resection of surrounding organs
• Those who developed intraoperative problems or complications that required conversion
• Those undergoing emergency surgery
• Those with evidence of peritoneal carcinomatosis
• Those with previous history of midline laparotomy
• Those who are expected to receive epidural opioids for postoperative pain management
• Those who are pregnant
• Those with cardiac pacemaker
• Those with coagulopathy
• Those who are allergic to the acupuncture needles

• Minimum Eligible Age: 18 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, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Simon SM Ng, MD

Role: CONTACT

simonng@surgery.cuhk.edu.hk

+852-35051495

Tony WC Mak, MD

Role: CONTACT

tonymak@surgery.cuhk.edu.hk

+852-35051495

Facility Contacts

Simon SM Ng, MD

Role: primary

simonng@surgery.cuhk.edu.hk

(852) 3505 1495

Tony WC Mak, MD

Role: backup

tonymak@surgery.cuhk.edu.hk

(852) 3505 1495

Other Identifiers

CREC 2017.668-T

Identifier Type: -

Identifier Source: org_study_id