Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT02531620
Status:
UNKNOWN
Last Update Posted:
2016-11-23
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-21', 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants recruiting', 'timeFrame': '6 months', 'description': 'Screening and recruiting of eligible patients'}], 'secondaryOutcomes': [{'measure': 'Post-op complications', 'timeFrame': '30 days', 'description': 'Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days'}, {'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'Survival will be noted at completion of 6 month study period.'}, {'measure': 'Length of Stay', 'timeFrame': '30 days post-op', 'description': 'Length of stay in hospital will be collected and compared for the two treatment groups'}, {'measure': 'Number of patients with readmissions', 'timeFrame': '30 days and 6 months', 'description': 'Number of patients with readmission to hospital during the 30 day and 6 month period will be compared for the two treatment groups'}, {'measure': 'Physical Function Assessment (6 Minute Walk Test)', 'timeFrame': '1, 3 and 6 months', 'description': '6 Minute Walk Test (6MWT)'}, {'measure': 'Symptom Assessment (Edmonton Symptom Assessment System)', 'timeFrame': '1, 3 and 6 months', 'description': 'Edmonton Symptom Assessment System (ESAS)'}, {'measure': 'Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)', 'timeFrame': '1, 3 and 6 months', 'description': 'UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)'}, {'measure': 'Quality of Life Survey (Short Form 36 Health Survey)', 'timeFrame': '1, 3 and 6 months', 'description': 'Short Form 36 Health Survey (SF-36)'}, {'measure': 'Pain Assessment (Visual Analog Scale)', 'timeFrame': '1, 3 and 6 months', 'description': 'Pain score by Visual Analog Scale'}, {'measure': 'Bowel Function Assessment', 'timeFrame': '1, 3 and 6 months', 'description': 'Bowel Function Index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prehabilitation', 'colorectal surgery'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '28600373', 'type': 'DERIVED', 'citation': 'Wong SG, Maida E, Harvey D, Wagner N, Sonnadara R, Amin N. Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. BMJ Open. 2017 Jun 9;7(6):e015565. doi: 10.1136/bmjopen-2016-015565.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.', 'detailedDescription': "Operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. For some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. As part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. It is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. Investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient\n* scheduled to undergo a colorectal resection as part of treatment for colorectal cancer.\n* English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits.\n\nExclusion Criteria:\n\n* geographic inaccessibility\n* unwilling to provide consent'}, 'identificationModule': {'nctId': 'NCT02531620', 'acronym': 'Prehab', 'briefTitle': 'Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)', 'orgStudyIdInfo': {'id': '2015A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiatry', 'description': 'Pre-operative Physiatry assessment and intervention', 'interventionNames': ['Other: Physiatry Assessment']}, {'type': 'OTHER', 'label': 'Routine Care', 'description': 'Patients will receive routine pre-operative care, this study arm does not have an intervention.', 'interventionNames': ['Other: Routine Care']}], 'interventions': [{'name': 'Physiatry Assessment', 'type': 'OTHER', 'description': "Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. The Investigators are proposing your participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.", 'armGroupLabels': ['Physiatry']}, {'name': 'Routine Care', 'type': 'OTHER', 'otherNames': ['Standard Care'], 'description': 'Usual care for your disease process', 'armGroupLabels': ['Routine Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nalin Amin, MD', 'role': 'CONTACT', 'phone': '905.522.1155', 'phoneExt': '37320'}], 'facility': 'St Joseph Healthcare Hamilton', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Nalin Amin, MD', 'role': 'CONTACT', 'email': 'amin@mcmaster.ca', 'phone': '905 522-1155', 'phoneExt': '32938'}, {'name': 'Susan Haley, BSc MSc', 'role': 'CONTACT', 'email': 'haleys@mcmaster.ca', 'phone': '905 521-2100', 'phoneExt': '32575'}], 'overallOfficials': [{'name': 'Nalin Amin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}