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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: acupuncture; Other: early recovery program after surgery

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyung Sang South Province
    • Yangsan, Kyung Sang South Province, Korea, Republic of, 626770
      • National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
    • Yangsan, Kyung Sang South Province, Korea, Republic of, 626770
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to enhanced recovery program after surgery	Number of patients who discharge the hospital at the expected day as planned	at 1 week after surgery (an expected day of discharge)

Collaborators and Investigators

• Sponsor: Korean Medicine Hospital of Pusan National University
• Investigators: Principal Investigator: Gi Young Yang, PhD, Korean Medicine Hospital, Pusan National University; Principal Investigator: Kyung Mo Son, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 1, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 25, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: cancer; colorectal; colon; neoplasm
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 03-2014-012