Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Procedure: Electroacupuncture
* Procedure: Fast-track program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br>Bilateral acupoints relevant to the treatment of abdominal pain, abdominal distension, and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian TE-6), will be used. Electric stimulation at a frequency of 50 Hz will be employed to the acupuncture needles. | Procedure: Electroacupuncture<br> <br> |
| Active Comparator: Fast-track program<br>The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation. | Procedure: Fast-track program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative hospital stay | Including hospital stay of patients who are readmitted within 30 days after surgery. | 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 | 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. | Up to 1 month | 
| Morbidity |  | Up to 1 month | 
| Mortality |  | Up to 1 month | 
| Readmission rate |  | 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 | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture, Fast track program, Postoperative ileus, Laparoscopic surgery, Colorectal surgery, Randomized controlled trial, Hospital stay