Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-04 @ 8:00 PM
Study NCT ID:
NCT02388256
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2015-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-25', 'studyFirstSubmitDate': '2015-03-01', 'studyFirstSubmitQcDate': '2015-03-09', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to enhanced recovery program after surgery', 'timeFrame': 'at 1 week after surgery (an expected day of discharge)', 'description': 'Number of patients who discharge the hospital at the expected day as planned'}], 'primaryOutcomes': [{'measure': 'Recovery of physical function', 'timeFrame': 'at 2 weeks after surgery', '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'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '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', 'description': 'Pain scores on a numeric rating scale. Score ranges from 0 (no pain at all) to 10 (the worst pain imaginable)'}, {'measure': 'Time to first flatus', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'elapsed time after surgery'}, {'measure': 'Time to tolerate soft diet', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'elapsed time after surgery'}, {'measure': 'Time to first defecation', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'elapsed time after surgery'}, {'measure': 'Time to independent walk', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'elapsed time after surgery'}, {'measure': 'Number of insertions of nasogastric tube', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'number of insertions of nasogastric tube'}, {'measure': 'Incidence of nausea/vomiting', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'number of nausea / vomiting reported by the patients'}, {'measure': 'Time to first removal of Foley catheter', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'elapsed time after surgery'}, {'measure': 'Number of reinsertions of Foley catheter', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'number of reinsertions of Foley catheter'}, {'measure': 'Number of clean intermittent catheterizations', 'timeFrame': 'up to 1 week after surgery (an expected period of admission)', 'description': 'number of clean intermittent catheterizations'}, {'measure': 'Quality of life measured by EORTC QLQ C30', 'timeFrame': 'at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery', 'description': 'Quality of life measured by EORTC QLQ C30'}, {'measure': "Patient's global assessment after surgery", 'timeFrame': 'at 4 weeks after surgery, at 12 weeks after surgery', 'description': 'Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.'}, {'measure': 'Use of medication', 'timeFrame': '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', 'description': 'Use of analgesics, antiemetics and other medications after surgery'}, {'measure': 'Anxiety and depression', 'timeFrame': 'at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery', 'description': "Patients' anxiety and depression level measured by the Hospital Anxiety-Depression Scale"}, {'measure': 'Postoperative complications', 'timeFrame': 'within 12 weeks after surgery', 'description': '* wound infection\n* urinary tract infection\n* urinary retention\n* chest infection\n* other infection\n* paralytic ileus'}, {'measure': 'Serious adverse events', 'timeFrame': 'within 12 weeks after surgery', 'description': '* respiratory failure requiring ventilation\n* renal failure requiring dialysis\n* cardiac failure\n* myocardial infarction\n* anastomotic leakage requiring surgery\n* anastomotic leakage requiring drainage\n* bowel obstruction/stricture requiring surgery\n* abdominal wall dehiscence requiring surgery\n* readmission within 30 days after surgery\n* reoperation within 30 days after surgery\n* mortality during surgery or within 30 days after surgery'}, {'measure': 'Adverse events related to acupuncture', 'timeFrame': 'within 12 weeks after surgery', 'description': 'Expected or unexpected adverse events that are considered to be associated with acupuncture treatments.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colon', 'colorectal', 'cancer', 'neoplasm'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "Background:\n\nPatients 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.\n\nObjective:\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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)\n* Patients aged 18 to 75\n* American Society of Anesthesiologists Grade 1 to 2\n* Eastern Cooperative Oncology Group Grade 0 to 2\n* Written informed consents\n\nExclusion Criteria:\n\n* Pregnancy\n* Inflammatory bowel disease\n* Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)\n* Resection of other organs for radical removal of colorectal cancer\n* Patients requiring enterolysis due to previous history of abdominal surgery\n* Obstructive colorectal cancer\n* Metastatic colorectal cancer\n* Cognitive impairment that may affect the patient's ability to complete the outcome assessments\n* Previous history of stroke\n* Previous history of sensitive reaction to acupuncture\n* Patients unable to cooperate with acupuncture treatments\n* Pacemaker implantation\n* Previous history of epilepsy\n* Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks\n* Patients who have participated in other trials within 3 months"}, 'identificationModule': {'nctId': 'NCT02388256', 'briefTitle': 'Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection', 'organization': {'class': 'OTHER', 'fullName': 'Korean Medicine Hospital of Pusan National University'}, 'officialTitle': 'Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection', 'orgStudyIdInfo': {'id': '03-2014-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Manual and electroacupuncture', 'interventionNames': ['Device: acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced recovery program after surgery', 'description': 'Enhanced recovery program after surgery', 'interventionNames': ['Device: acupuncture', 'Other: early recovery program after surgery']}], 'interventions': [{'name': 'acupuncture', 'type': 'DEVICE', '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).\n\nRationale 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.', 'armGroupLabels': ['Acupuncture', 'Enhanced recovery program after surgery']}, {'name': 'early recovery program after surgery', 'type': 'OTHER', 'otherNames': ['fast-track recovery program'], '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.', 'armGroupLabels': ['Enhanced recovery program after surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '626770', 'city': 'Yangsan', 'state': 'Kyung Sang South Province', 'country': 'South Korea', 'facility': 'National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '626770', 'city': 'Yangsan', 'state': 'Kyung Sang South Province', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Kyung Mo Son, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}, {'name': 'Gi Young Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korean Medicine Hospital, Pusan National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Medicine Hospital of Pusan National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Gyung-Mo Son', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}