Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-25 @ 12:03 AM
Study NCT ID:
NCT02059603
Status:
UNKNOWN
Last Update Posted:
2014-02-11
First Post:
2014-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-10', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to defecation', 'timeFrame': 'Up to 1 month', 'description': 'Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.'}], 'secondaryOutcomes': [{'measure': 'Total postoperative hospital stay', 'timeFrame': 'Up to 1 month', 'description': 'Including hospital stay of patients who are readmitted within 30 days after surgery.'}, {'measure': 'Time of first passing flatus reported by the patients', 'timeFrame': 'Up to 1 month'}, {'measure': 'Time that the patients tolerated solid diet', 'timeFrame': 'Up to 1 month'}, {'measure': 'Time to walk independently', 'timeFrame': 'Up to 1 month'}, {'measure': 'Pain scores on visual analog scale', 'timeFrame': 'Up to 1 month', 'description': 'From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.'}, {'measure': 'Morbidity', 'timeFrame': 'Up to 1 month'}, {'measure': 'Mortality', 'timeFrame': 'Up to 1 month'}, {'measure': 'Readmission rate', 'timeFrame': 'Up to 1 month'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 1 month', 'description': 'Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Electroacupuncture', 'Fast track program', 'Postoperative ileus', 'Laparoscopic surgery', 'Colorectal surgery', 'Randomized controlled trial', 'Hospital stay'], 'conditions': ['Postoperative Ileus']}, 'descriptionModule': {'briefSummary': "Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.\n\nObjectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.\n\nDesign: Prospective, randomized, noninferiority trial.\n\nSubjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.\n\nInterventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.\n\nOutcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.\n\nConclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer\n* Age of patients between 18 and 80 years\n* Patients with American Society of Anesthesiologists (ASA) grading I-II\n* Patients with no severe physical disability\n* Patients who require no assistance with the activities of daily living\n* Informed consent available\n\nExclusion Criteria:\n\n* Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy\n* Patients with planned stoma creation\n* Patients undergoing emergency surgery\n* Patients with evidence of peritoneal carcinomatosis\n* Patients with previous history of midline laparotomy\n* Patients who are expected to receive epidural opioids for postoperative pain management\n* Patients with cardiac pacemaker\n* Patients who are allergic to the acupuncture needles'}, 'identificationModule': {'nctId': 'NCT02059603', 'briefTitle': 'Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery', 'orgStudyIdInfo': {'id': 'CRE-2013.009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture', 'description': 'Bilateral acupoints relevant to the treatment of abdominal pain, abdominal distension, and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian TE-6), will be used. Electric stimulation at a frequency of 50 Hz will be employed to the acupuncture needles.', 'interventionNames': ['Procedure: Electroacupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fast-track program', 'description': 'The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation.', 'interventionNames': ['Procedure: Fast-track program']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'armGroupLabels': ['Electroacupuncture']}, {'name': 'Fast-track program', 'type': 'PROCEDURE', 'armGroupLabels': ['Fast-track program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Simon SM Ng, MD', 'role': 'CONTACT', 'email': 'simonng@surgery.cuhk.edu.hk', 'phone': '(852) 2632 1495'}, {'name': 'Tony WC Mak, MD', 'role': 'CONTACT', 'email': 'tonymak@surgery.cuhk.edu.hk', 'phone': '(852) 2632 1495'}, {'name': 'Simon SM Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tony WC Mak, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Simon S. M. Ng, MD', 'role': 'CONTACT', 'email': 'simonng@surgery.cuhk.edu.hk', 'phone': '(852) 2632 1495'}], 'overallOfficials': [{'name': 'Simon S. M. Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Simon S. M. Ng', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}