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Trial record 50 of 1002 for:    colon cancer AND resection

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

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ClinicalTrials.gov Identifier: NCT02388256
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Gyung-Mo Son, Pusan National University Yangsan Hospital

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: acupuncture Other: early recovery program after surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Manual and electroacupuncture
Device: 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.


Active Comparator: Enhanced recovery program after surgery
Enhanced recovery program after surgery
Device: 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.


Other: 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.
Other Name: fast-track recovery program




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388256


Locations
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Korea, Republic of
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
Yangsan, Kyung Sang South Province, Korea, Republic of, 626770
Pusan National University Yangsan Hospital
Yangsan, Kyung Sang South Province, Korea, Republic of, 626770
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Investigators
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Principal Investigator: Kyung Mo Son, PhD Pusan National University Yangsan Hospital
Principal Investigator: Gi Young Yang, PhD Korean Medicine Hospital, Pusan National University

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Responsible Party: Gyung-Mo Son, Associate professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT02388256     History of Changes
Other Study ID Numbers: 03-2014-012
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Keywords provided by Gyung-Mo Son, Pusan National University Yangsan Hospital:
colon
colorectal
cancer
neoplasm
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases