Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: acupuncture
* Other: early recovery program after surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Manual and electroacupuncture | Device: acupuncture<br>* 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.<br>|
| Active Comparator: Enhanced recovery program after surgery<br>Enhanced recovery program after surgery | Device: acupuncture<br>* 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.<br>Other: early recovery program after surgery<br>* 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.<br>* Other names: fast-track recovery program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain scores on a numeric rating scale. Score ranges from 0 (no pain at all) to 10 (the worst pain imaginable) | 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 | up to 1 week after surgery (an expected period of admission) | 
| Time to tolerate soft diet | elapsed time after surgery | up to 1 week after surgery (an expected period of admission) | 
| Time to first defecation | elapsed time after surgery | up to 1 week after surgery (an expected period of admission) | 
| Time to independent walk | elapsed time after surgery | up to 1 week after surgery (an expected period of admission) | 
| Number of insertions of nasogastric tube | number of insertions of nasogastric tube | up to 1 week after surgery (an expected period of admission) | 
| Incidence of nausea/vomiting | number of nausea / vomiting reported by the patients | up to 1 week after surgery (an expected period of admission) | 
| Time to first removal of Foley catheter | elapsed time after surgery | up to 1 week after surgery (an expected period of admission) | 
| Number of reinsertions of Foley catheter | number of reinsertions of Foley catheter | up to 1 week after surgery (an expected period of admission) | 
| Number of clean intermittent catheterizations | number of clean intermittent catheterizations | 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 | 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. | at 4 weeks after surgery, at 12 weeks after surgery | 
| Use of medication | Use of analgesics, antiemetics and other medications after surgery | 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 | 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 | 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 | within 12 weeks after surgery | 
| Adverse events related to acupuncture | Expected or unexpected adverse events that are considered to be associated with acupuncture treatments. | within 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon, colorectal, cancer, neoplasm