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Colorectal CancerNCT02388256

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

A study testing acupuncture and early recovery program after surgery in people with Colorectal Cancer, run by Korean Medicine Hospital of Pusan National University at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
acupuncture and early recovery program after surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesSouth Korea
Study dates
Mar 2015to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

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

    Yangsan, Kyung Sang South Province, 626770

  • Pusan National University Yangsan Hospital

    Yangsan, Kyung Sang South Province, 626770

Other trials in South Korea

About this study

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.

Read more

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.

Being tested
acupuncture, early recovery program after surgery
Keywords
colon, colorectal, cancer, neoplasm
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • early recovery program after surgeryOther

    Also called fast-track recovery program

    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.

Study groups in NCT02388256
Study groupRoleWhat they receive
AcupunctureExperimentalManual and electroacupuncture
Receives: Device: acupuncture
Enhanced recovery program after surgeryActive comparatorEnhanced recovery program after surgery
Receives: Device: acupuncture; Other: early recovery program after surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at 2 weeks after surgery

Secondary outcomes (17)

  1. Pain intensity

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

    Measured: 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

  2. Time to first flatus

    elapsed time after surgery

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

  3. Time to tolerate soft diet

    elapsed time after surgery

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

  4. Time to first defecation

    elapsed time after surgery

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

  5. Time to independent walk

    elapsed time after surgery

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

  6. Number of insertions of nasogastric tube

    number of insertions of nasogastric tube

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

  7. Incidence of nausea/vomiting

    number of nausea / vomiting reported by the patients

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

  8. Time to first removal of Foley catheter

    elapsed time after surgery

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

  9. Number of reinsertions of Foley catheter

    number of reinsertions of Foley catheter

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

  10. Number of clean intermittent catheterizations

    number of clean intermittent catheterizations

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

  11. Quality of life measured by EORTC QLQ C30

    Quality of life measured by EORTC QLQ C30

    Measured: at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery

  12. Patient's global assessment after surgery

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

    Measured: at 4 weeks after surgery, at 12 weeks after surgery

  13. Use of medication

    Use of analgesics, antiemetics and other medications after surgery

    Measured: 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

  14. Anxiety and depression

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

    Measured: at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery

  15. Postoperative complications

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

    Measured: within 12 weeks after surgery

  16. 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

    Measured: within 12 weeks after surgery

  17. Adverse events related to acupuncture

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

    Measured: within 12 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionFeb 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388256
Sponsor's protocol ID
03-2014-012
Status last verified
Jun 2016
First submitted
1 Mar 2015
Last updated
28 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture and early recovery program after surgery in people with Colorectal Cancer, run by Korean Medicine Hospital of Pusan National University at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery of physical function (time frame: at 2 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02388256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.

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