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

NCT ID: NCT02388256

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-04-30

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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture

Manual and electroacupuncture

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

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.

Enhanced recovery program after surgery

Enhanced recovery program after surgery

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type DEVICE

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.

early recovery program after surgery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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fast-track recovery program

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Medicine Hospital of Pusan National University

OTHER

Sponsor Role lead

Responsible Party

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Gyung-Mo Son

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Mo Son, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Gi Young Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Korean Medicine Hospital, Pusan National University

Locations

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

Yangsan, Kyung Sang South Province, South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, Kyung Sang South Province, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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03-2014-012

Identifier Type: -

Identifier Source: org_study_id

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