Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
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About
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.
Enrollment
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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
Trial design
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Interventional model
Masking
72 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Tony WC Mak, MD; Simon SM Ng, MD
Data sourced from clinicaltrials.gov
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