Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
- Conditions
- Colorectal Cancer
- Interventions
- Device: acupunctureOther: early recovery program after surgery
- Registration Number
- NCT02388256
- Lead Sponsor
- Korean Medicine Hospital of Pusan National University
- Brief Summary
Background:
Patients who undergo laparoscopic surgical resection of colorectal cancer may experience various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation of daily activities (e.g., walking capacity). There is also a risk of post-operative complications and a prolonged hospital stay due to complications. Patients who underwent surgical resection may have experienced chronic pain, anxiety/depression, or diminished quality of life. The physical, psychological, and functional aspects of patients' disorders imply the necessity of multidisciplinary care, including complementary or traditional medicines such as acupuncture. This study aims to assess whether acupuncture treatment, combined with an enhanced recovery program after surgery in an inpatient care setting is effective than only an enhanced recovery program after surgery.
Objective:
To assess the effectiveness and safety of acupuncture combined with an enhanced recovery program after surgery to reduce postoperative symptoms and improve functional recovery and the patients' quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)
- Patients aged 18 to 75
- American Society of Anesthesiologists Grade 1 to 2
- Eastern Cooperative Oncology Group Grade 0 to 2
- Written informed consents
- Pregnancy
- Inflammatory bowel disease
- Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)
- Resection of other organs for radical removal of colorectal cancer
- Patients requiring enterolysis due to previous history of abdominal surgery
- Obstructive colorectal cancer
- Metastatic colorectal cancer
- Cognitive impairment that may affect the patient's ability to complete the outcome assessments
- Previous history of stroke
- Previous history of sensitive reaction to acupuncture
- Patients unable to cooperate with acupuncture treatments
- Pacemaker implantation
- Previous history of epilepsy
- Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks
- Patients who have participated in other trials within 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced recovery program after surgery early recovery program after surgery Enhanced recovery program after surgery Enhanced recovery program after surgery acupuncture Enhanced recovery program after surgery Acupuncture acupuncture Manual and electroacupuncture
- Primary Outcome Measures
Name Time Method Recovery of physical function at 2 weeks after surgery Recovery of physical function, as measured by the physical function domain of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 instrument
- Secondary Outcome Measures
Name Time Method Time to tolerate soft diet up to 1 week after surgery (an expected period of admission) elapsed time after surgery
Time to independent walk up to 1 week after surgery (an expected period of admission) elapsed time after surgery
Quality of life measured by EORTC QLQ C30 at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery Quality of life measured by EORTC QLQ C30
Anxiety and depression at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery Patients' anxiety and depression level measured by the Hospital Anxiety-Depression Scale
Incidence of nausea/vomiting up to 1 week after surgery (an expected period of admission) number of nausea / vomiting reported by the patients
Number of reinsertions of Foley catheter up to 1 week after surgery (an expected period of admission) number of reinsertions of Foley catheter
Use of medication at 1 week after surgery (an expected day of discharge), at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery Use of analgesics, antiemetics and other medications after surgery
Postoperative complications within 12 weeks after surgery * wound infection
* urinary tract infection
* urinary retention
* chest infection
* other infection
* paralytic ileusAdverse events related to acupuncture within 12 weeks after surgery Expected or unexpected adverse events that are considered to be associated with acupuncture treatments.
Pain intensity at 4, 12, 24, 48, 72 hours after surgery, at 1 week after surgery (an expected day of discharge), at 2 weeks after surgery, and at 4 weeks after surgery Pain scores on a numeric rating scale. Score ranges from 0 (no pain at all) to 10 (the worst pain imaginable)
Number of insertions of nasogastric tube up to 1 week after surgery (an expected period of admission) number of insertions of nasogastric tube
Time to first removal of Foley catheter up to 1 week after surgery (an expected period of admission) elapsed time after surgery
Serious adverse events within 12 weeks after surgery * respiratory failure requiring ventilation
* renal failure requiring dialysis
* cardiac failure
* myocardial infarction
* anastomotic leakage requiring surgery
* anastomotic leakage requiring drainage
* bowel obstruction/stricture requiring surgery
* abdominal wall dehiscence requiring surgery
* readmission within 30 days after surgery
* reoperation within 30 days after surgery
* mortality during surgery or within 30 days after surgeryTime to first flatus up to 1 week after surgery (an expected period of admission) elapsed time after surgery
Time to first defecation up to 1 week after surgery (an expected period of admission) elapsed time after surgery
Number of clean intermittent catheterizations up to 1 week after surgery (an expected period of admission) number of clean intermittent catheterizations
Patient's global assessment after surgery at 4 weeks after surgery, at 12 weeks after surgery Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.
Trial Locations
- Locations (2)
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
🇰🇷Yangsan, Kyung Sang South Province, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Kyung Sang South Province, Korea, Republic of