Postoperative Ileus
Conditions
Keywords
Electroacupuncture, Fast track program, Postoperative ileus, Laparoscopic surgery, Colorectal surgery, Randomized controlled trial, Hospital stay
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.
Interventions
PROCEDUREElectroacupuncture
PROCEDUREFast-track program
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to defecation | Up to 1 month | Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Total postoperative hospital stay | Up to 1 month | Including hospital stay of patients who are readmitted within 30 days after surgery. |
| Mortality | Up to 1 month | — |
| Readmission rate | Up to 1 month | — |
| Quality of life | Up to 1 month | Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires |
| Morbidity | Up to 1 month | — |
Countries
China
Contacts
Primary ContactSimon S. M. Ng, MD
Outcome results
None listed