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OpenTrials
Completed

NCT Number: NCT02388256

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

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

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.

Other names: fast-track recovery program

Primary outcomes

  1. Recovery of physical function

    Time frame: at 2 weeks after surgery

    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 outcomes

  1. Pain intensity

    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

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

  2. Time to first flatus

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

    elapsed time after surgery

  3. Time to tolerate soft diet

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

    elapsed time after surgery

  4. Time to first defecation

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

    elapsed time after surgery

  5. Time to independent walk

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

    elapsed time after surgery

  6. Number of insertions of nasogastric tube

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

    number of insertions of nasogastric tube

  7. Incidence of nausea/vomiting

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

    number of nausea / vomiting reported by the patients

  8. Time to first removal of Foley catheter

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

    elapsed time after surgery

  9. Number of reinsertions of Foley catheter

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

    number of reinsertions of Foley catheter

  10. Number of clean intermittent catheterizations

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

    number of clean intermittent catheterizations

  11. Quality of life measured by EORTC QLQ C30

    Time frame: at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery

    Quality of life measured by EORTC QLQ C30

  12. Patient's global assessment after surgery

    Time frame: at 4 weeks after surgery, at 12 weeks after surgery

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

  13. Use of medication

    Time frame: 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

    Use of analgesics, antiemetics and other medications after surgery

  14. Anxiety and depression

    Time frame: at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery

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

  15. Postoperative complications

    Time frame: within 12 weeks after surgery

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

  16. Serious adverse events

    Time frame: within 12 weeks after surgery

    • 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

  17. Adverse events related to acupuncture

    Time frame: within 12 weeks after surgery

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

Other outcomes

  1. Adherence to enhanced recovery program after surgery

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

    Number of patients who discharge the hospital at the expected day as planned

Sponsors and collaborators

Lead sponsor

Korean Medicine Hospital of Pusan National University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2015
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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