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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
30
Points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4) and Pericardium 6 (PC6) will be used. Electrical stimulation with alternating frequency of 2 to 100 Hz will be applied to the selected points (LI4 to LI11, ST36 to ST37, and bilateral SP6). Rationale of acupuncture treatments will include both traditional theory of harmonizing gastrointestinal function and strengthening vital energy as well as modern experimental and clinical evidence of regulating gastrointestinal motility and other symptom managements. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience.
An enhanced recovery program after surgery that was designed and is currently implemented by surgeons, anesthetists, dietitians, and nurses will be provided. The program includes preoperative education, early water/food intake, early mobilization, early removal of Foley catheter and drains, structured nursing care, and nutritional support.
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
Yangsan, Kyung Sang South Province, South Korea
Pusan National University Yangsan Hospital
Yangsan, Kyung Sang South Province, South Korea
Recovery of physical function
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
Time frame: at 2 weeks after surgery
Pain intensity
Pain scores on a numeric rating scale. Score ranges from 0 (no pain at all) to 10 (the worst pain imaginable)
Time frame: 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
Time to first flatus
elapsed time after surgery
Time frame: up to 1 week after surgery (an expected period of admission)
Time to tolerate soft diet
elapsed time after surgery
Time frame: up to 1 week after surgery (an expected period of admission)
Time to first defecation
elapsed time after surgery
Time frame: up to 1 week after surgery (an expected period of admission)
Time to independent walk
elapsed time after surgery
Time frame: up to 1 week after surgery (an expected period of admission)
Number of insertions of nasogastric tube
number of insertions of nasogastric tube
Time frame: up to 1 week after surgery (an expected period of admission)
Incidence of nausea/vomiting
number of nausea / vomiting reported by the patients
Time frame: up to 1 week after surgery (an expected period of admission)
Time to first removal of Foley catheter
elapsed time after surgery
Time frame: up to 1 week after surgery (an expected period of admission)
Number of reinsertions of Foley catheter
number of reinsertions of Foley catheter
Time frame: up to 1 week after surgery (an expected period of admission)
Number of clean intermittent catheterizations
number of clean intermittent catheterizations
Time frame: up to 1 week after surgery (an expected period of admission)
Quality of life measured by EORTC QLQ C30
Quality of life measured by EORTC QLQ C30
Time frame: at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery
Patient's global assessment after surgery
Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.
Time frame: at 4 weeks after surgery, at 12 weeks after surgery
Use of medication
Use of analgesics, antiemetics and other medications after surgery
Time frame: 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
Anxiety and depression
Patients' anxiety and depression level measured by the Hospital Anxiety-Depression Scale
Time frame: at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery
Postoperative complications
* wound infection * urinary tract infection * urinary retention * chest infection * other infection * paralytic ileus
Time frame: within 12 weeks after surgery
Serious adverse events
* 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 surgery
Time frame: within 12 weeks after surgery
Adverse events related to acupuncture
Expected or unexpected adverse events that are considered to be associated with acupuncture treatments.
Time frame: within 12 weeks after surgery
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