Clinical trial NCT02059603: Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Ileus
Keywords: Electroacupuncture
Fast track program
Postoperative ileus
Laparoscopic surgery
Colorectal surgery
Randomized controlled trial
Hospital stay
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

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: Morbidity
timeFrame: Up to 1 month
measure: Mortality
timeFrame: Up to 1 month
measure: Readmission rate
timeFrame: Up to 1 month
measure: Quality of life
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 S. M. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: