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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

acupuncture

early recovery program after surgery

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colon, colorectal, cancer, neoplasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture

Enhanced recovery program after surgery

Arm Description

Manual and electroacupuncture

Enhanced recovery program after surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain intensity

Pain scores on a numeric rating scale. Score ranges from 0 (no pain at all) to 10 (the worst pain imaginable)

Time to first flatus

elapsed time after surgery

Time to tolerate soft diet

elapsed time after surgery

Time to first defecation

elapsed time after surgery

Time to independent walk

elapsed time after surgery

Number of insertions of nasogastric tube

number of insertions of nasogastric tube

Incidence of nausea/vomiting

number of nausea / vomiting reported by the patients

Time to first removal of Foley catheter

elapsed time after surgery

Number of reinsertions of Foley catheter

number of reinsertions of Foley catheter

Number of clean intermittent catheterizations

number of clean intermittent catheterizations

Quality of life measured by EORTC QLQ C30

Patient's global assessment after surgery

Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.

Use of medication

Use of analgesics, antiemetics and other medications after surgery

Anxiety and depression

Patients' anxiety and depression level measured by the Hospital Anxiety-Depression Scale

Postoperative complications

wound infection urinary tract infection urinary retention chest infection other infection paralytic ileus

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

Adverse events related to acupuncture

Expected or unexpected adverse events that are considered to be associated with acupuncture treatments.

Full Information

NCT ID

NCT02388256

First Posted

March 1, 2015

Last Updated

June 25, 2016

Sponsor

Korean Medicine Hospital of Pusan National University

1. Study Identification

Unique Protocol Identification Number

NCT02388256

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korean Medicine Hospital of Pusan National University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

colon, colorectal, cancer, neoplasm

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Manual and electroacupuncture

Arm Title

Enhanced recovery program after surgery

Arm Type

Active Comparator

Arm Description

Enhanced recovery program after surgery

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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

Other

Intervention Name(s)

early recovery program after surgery

Other Intervention Name(s)

fast-track recovery program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recovery of physical function

Description

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

Secondary Outcome Measure Information:

Title

Pain intensity

Description

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

Title

Time to first flatus

Description

elapsed time after surgery

Time Frame