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

NCT04090073 | Unknown DMC

• 1 other identifier: CREC 2017.668-T
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to defecation

  Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.

  Up to 1 month

Secondary Outcomes (12)

• Total postoperative hospital stay

  Up to 1 month

• Time of first passing flatus reported by the patients

  Up to 1 month

• Time that the patients tolerated solid diet

  Up to 1 month

• Time to walk independently

  Up to 1 month

• Pain scores on visual analog scale

  Up to 1 month

Study Arms (2)

Electroacupuncture Plus Fast-track Perioperative Program

EXPERIMENTAL

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.

Procedure: Electroacupuncture; Other: Fast-track Perioperative program

Fast-track Perioperative Program

ACTIVE COMPARATOR

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

Other: Fast-track Perioperative program

Interventions

Electroacupuncture PROCEDURE

As above

Electroacupuncture Plus Fast-track Perioperative Program

Fast-track Perioperative program OTHER

As above

Electroacupuncture Plus Fast-track Perioperative Program; Fast-track Perioperative Program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, 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

+852-35051495; simonng@surgery.cuhk.edu.hk

Tony WC Mak, MD

CONTACT

+852-35051495; tonymak@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)