Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT01438268
Status:
UNKNOWN
Last Update Posted:
2013-11-19
First Post:
2011-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-15', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-09-20', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27', 'timeFrame': 'On average between 18 and 24 hours postoperatively', 'description': 'The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)'}, {'measure': 'The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27', 'timeFrame': 'on average between 48-72 hours postoperatively', 'description': 'The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)'}, {'measure': 'The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27', 'timeFrame': 'On average 72-96 hours post operatively', 'description': 'The patient will be contacted by the study coordinator, 4 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)'}, {'measure': 'The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27', 'timeFrame': 'On average 7-8 days postoperatively', 'description': 'The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome measure is the quality of recovery as assessed by the VAS pain score', 'timeFrame': 'This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above', 'description': 'These scores will be compared'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Diseases']}, 'descriptionModule': {'briefSummary': 'Specific Aim: To assess the quality of recovery of patients following early discharge (18 hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.\n\nClinical Relevance: Postoperative recovery is a complex process related to various outcomes such as physiological endpoints, incidence of adverse events and change in psychological status. Previous studies of recovery after surgery and anesthesia have focused primarily on the physiological endpoints and the incidence of adverse events. Much of the work has occurred in specialties dealing with chronic disease states such as cancer, rheumatology and musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in the ambulatory population for postoperative recovery. Here the investigators propose to measure postoperative recovery outcomes within the first week following a TRAM flap reconstructive procedure using a validated postoperative quality of recovery instrument (QoR-27) and a 100 mm VAS for pain.', 'detailedDescription': "Women's College Hospital is the first and only independent ambulatory care hospital in Ontario, and the only hospital in Ontario with a primary focus on women's health. Patients undergoing breast reconstruction following breast cancer at our institution are now undergoing expedited discharge at 18 hrs postoperatively. To facilitate next day discharge, a multidisciplinary group was formed to determine the best evidence for perioperative care to ensure patient safety and excellent postoperative recovery. Minimizing length of stay has obvious cost savings for hospitals, but for patients the advantages include minimizing exposure to hospital-acquired infections and an earlier return to their more familiar home environment. The need to balance the advantage of early discharge to patient complications, however, must be addressed. As other hospitals across the country face the same length of stay constraints as has been our experience, this study will provide important data on the quality of recovery of patients undergoing early discharge following breast reconstructive surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Reconstructive breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing any type of TRAM flap\n* Age\\<75 yrs\n* Non-smoker\n\nExclusion Criteria:\n\n* History of chronic pain or psychiatric disturbance\n* History of chronic use of opioid medications\n* Allergy to local anesthesia or opioid medication\n* Inability to communicate in English\n* BMI\\>35'}, 'identificationModule': {'nctId': 'NCT01438268', 'acronym': 'TRAM', 'briefTitle': 'TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes', 'organization': {'class': 'OTHER', 'fullName': "Women's College Hospital"}, 'officialTitle': 'Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes', 'orgStudyIdInfo': {'id': '2010-0050-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reconstructive breast cancer patients', 'description': 'Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 1B2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Women's College Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'John L Semple, MD, MSc, FRCSC, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's College Hospital"}, {'name': 'Pamela J Morgan, MD, CCFP, FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': "Women's College Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's College Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}, {'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}