NCT02388256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

March 1, 2015

Last Update Submit

June 25, 2016

Conditions

Colorectal Cancer

Keywords

coloncolorectalcancerneoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • 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

  • Time to first flatus

    up to 1 week after surgery (an expected period of admission)

  • Time to tolerate soft diet

    up to 1 week after surgery (an expected period of admission)

  • Time to first defecation

    up to 1 week after surgery (an expected period of admission)

  • Time to independent walk

    up to 1 week after surgery (an expected period of admission)

  • +12 more secondary outcomes

Other Outcomes (1)

  • Adherence to enhanced recovery program after surgery

    at 1 week after surgery (an expected day of discharge)

Study Arms (2)

Acupuncture

EXPERIMENTAL

Manual and electroacupuncture

Device: acupuncture

Enhanced recovery program after surgery

ACTIVE COMPARATOR

Enhanced recovery program after surgery

Device: acupunctureOther: early recovery program after surgery

Interventions

acupunctureDEVICE

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.

AcupunctureEnhanced recovery program after surgery
early recovery program after surgeryOTHER

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.

Also known as: fast-track recovery program
Enhanced recovery program after surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University

Yangsan, Kyung Sang South Province, 626770, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Kyung Sang South Province, 626770, South Korea

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Kyung Mo Son, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

  • Gi Young Yang, PhD

    Korean Medicine Hospital, Pusan National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 1, 2015

First Posted

March 13, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

KR(2)