Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT01341366
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2011-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D009369', 'term': 'Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': 'Up to 1 month', 'description': 'Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'Up to 1 week', 'description': 'Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)'}, {'measure': 'Morbidity and mortality', 'timeFrame': 'Up to 1 month'}, {'measure': 'Readmission rate', 'timeFrame': 'Up to 1 month'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 1 month', 'description': 'Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires'}, {'measure': 'Direct/indirect medical costs and out-of-hospital economic costs', 'timeFrame': 'Up to 1 month'}, {'measure': 'Systemic cytokine responses', 'timeFrame': 'Up to 1 week', 'description': 'Blood levels of IL-1β, IL-6, and C-reactive protein'}, {'measure': 'Lymphocyte subsets', 'timeFrame': 'Up to 1 week', 'description': 'Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic surgery'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.surgery.cuhk.edu.hk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nLaparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been introduced in the West to optimize perioperative factors to reduce the physiological/psychological stress of open colorectal surgery. However, few studies have evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal surgery.\n\nObjective:\n\nTo compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track" perioperative program.\n\nDesign:\n\nProspective randomized trial.\n\nSubjects:\n\nOne hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection of non-metastatic colonic and upper rectal cancer will be recruited.\n\nInterventions:\n\nPatients will be randomized to a "traditional" or a "fast-track" perioperative program.\n\nOutcome measures:\n\nPrimary outcome: total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters (including systemic cytokine response and cell-mediated immune function), morbidity and mortality, quality of life, and medical costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 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 75 years\n* Patients with American Society of Anesthesiologists 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 known metastatic disease\n* Patients with previous history of abdominal surgery\n* Patients with known immunological dysfunction\n* Patients who are taking steroids or immunosuppressive agents\n* Patients with chronic pain syndrome'}, 'identificationModule': {'nctId': 'NCT01341366', 'briefTitle': 'Fast-track Perioperative Program for Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Laparoscopic Colorectal Surgery in Hong Kong Chinese Patients: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'CRE-2008.552-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fast-track perioperative program', 'interventionNames': ['Other: Fast-track perioperative program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional perioperative program', 'interventionNames': ['Other: Traditional perioperative program']}], 'interventions': [{'name': 'Fast-track perioperative program', 'type': 'OTHER', 'description': 'Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization', 'armGroupLabels': ['Fast-track perioperative program']}, {'name': 'Traditional perioperative program', 'type': 'OTHER', 'description': 'Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon', 'armGroupLabels': ['Traditional perioperative program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Prince of Wales Hospital, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Simon SM 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', 'investigatorFullName': 'Simon S. M. Ng', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}