Clinical trial NCT04090073: Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Official title: Electroacupuncture Combined With Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to defecation
timeFrame: Up to 1 month
Secondary outcomes:
measure: Total postoperative hospital stay
timeFrame: Up to 1 month
measure: Time of first passing flatus reported by the patients
timeFrame: Up to 1 month
measure: Time that the patients tolerated solid diet
timeFrame: Up to 1 month
measure: Time to walk independently
timeFrame: Up to 1 month
measure: Pain scores on visual analog scale
timeFrame: Up to 1 month
measure: Postoperative 30-day morbidity
timeFrame: Up to 1 month
measure: Incidence rate of adverse events related to electroacupuncture
timeFrame: Up to 1 month
measure: Readmission rate
timeFrame: Up to 1 month
measure: Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery
timeFrame: Up to 1 month
measure: Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 2 and 4 weeks after surgery
timeFrame: Up to 1 month
measure: Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery
timeFrame: Up to 1 month
measure: Direct/indirect medical costs and out-of-hospital economic costs
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: