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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, China
RECRUITINGTime to defecation
Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.
Time frame: Up to 1 month
Total postoperative hospital stay
Including hospital stay of patients who are readmitted within 30 days after surgery.
Time frame: Up to 1 month
Time of first passing flatus reported by the patients
Time frame: Up to 1 month
Time that the patients tolerated solid diet
Time frame: Up to 1 month
Time to walk independently
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
Morbidity
Time frame: Up to 1 month
Mortality
Time frame: Up to 1 month
Readmission rate
Time frame: Up to 1 month
Quality of life
Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
Time frame: Up to 1 month
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