Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT01260233
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2010-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'smoking cessation', 'timeFrame': 'date of surgery', 'description': 'Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.'}], 'secondaryOutcomes': [{'measure': 'smoking cessation/reduction', 'timeFrame': 'day of surgery', 'description': 'Smoking cessation/reduction by self-report. Smoking cessation defined as zero cigarettes in the 7 days before surgery (but exhaled CO \\> 7ppm) Reduction defined as 50% or less of initial self-report.'}, {'measure': 'Intraoperative complications and immediate post-operative complications', 'timeFrame': 'day of surgery', 'description': 'Events occurring in the operating room or post-anesthetic care unit (PACU) as reported by a blinded anesthesiologist or blinded PACU nurse:\n\nCardiovascular complications, Respiratory complications, Other (detailed description exceeds character limits)'}, {'measure': 'Time until PACU readiness for discharge / actual time in PACU', 'timeFrame': 'day of surgery', 'description': 'The time of arrival in PACU until the time the patient is deemed ready for discharge in accordance with hospital routine scoring system. The actual time spent in PACU (arrival until discharge) will also be compared.\n\nPatients bypassing PACU (e.g. patients having only sedation transferred directly from the operating room to surgical daycare prior to discharge home) will be considered separately.'}, {'measure': 'Unanticipated hospital admission', 'timeFrame': 'day of surgery', 'description': 'Patient booked as one-day stay, but later admitted to inpatient ward.'}, {'measure': 'Hospital length of stay', 'timeFrame': 'until hospital discharge', 'description': 'For inpatients only, the time from admission to surgical daycare until the patient is discharged home from the hospital.'}, {'measure': 'Smoking cessation at 12 months', 'timeFrame': '1 year', 'description': 'Self-reported smoking zero cigarettes in the 7 days prior to phone call. Phone call will occur at any time during the 12th month after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'complications', 'cigarettes', 'preoperative', 'perioperative', 'surgery', 'education', 'nicotine replacement therapy'], 'conditions': ['Smoking', 'Tobacco Use']}, 'referencesModule': {'references': [{'pmid': '25695576', 'type': 'DERIVED', 'citation': 'Lee SM, Landry J, Jones PM, Buhrmann O, Morley-Forster P. Long-term quit rates after a perioperative smoking cessation randomized controlled trial. Anesth Analg. 2015 Mar;120(3):582-587. doi: 10.1213/ANE.0000000000000555.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared.', 'detailedDescription': "Previous studies have shown that patients have up to one-third fewer complications after surgery when they quit smoking at least several weeks before surgery. Nicotine replacement therapy (which relieves cravings for cigarettes) and support by healthcare professionals have been shown to help patients quit smoking, particularly when encountering a major health event (e.g. surgery). In addition, quitting smoking in preparation for surgery sometimes results in quitting for a longer period of time after surgery, giving these patients the health benefits of long-term smoking cessation such as reduced rates of cancer and heart disease.\n\nThe preadmission clinic at St. Joseph's Health Care, London, Ontario, is assessing how effective a new 'Stop Smoking' program is for patients preparing for surgery. The program will include brief counselling in the clinic, smoking cessation brochures, six weeks of free transdermal nicotine replacement therapy and a referral to the Canadian Cancer Society's Smokers' Helpline telephone advice line. Patients that are smokers and preparing for their elective surgery will be invited to join the study, then be assigned to a group that either participates in the program or not. These groups will then be compared in terms of success at quitting smoking and complication rates around the time of surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* smokers (defined as those that smoke at least 2 cigarettes per day and have smoked within the last 7 days)\n* over age 18\n* presenting to preadmission clinic at St. Joseph's Health Care at least 3 weeks prior to scheduled date of surgery\n\nExclusion Criteria:\n\n* less than age 18\n* poor proficiency in English language\n* pregnant\n* breastfeeding\n* unable to consent due to severe mental illness or dementia\n* actively participating in another smoking cessation trial"}, 'identificationModule': {'nctId': 'NCT01260233', 'briefTitle': 'Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'R-10-476'}, 'secondaryIdInfos': [{'id': '17342', 'type': 'OTHER', 'domain': 'UWO Health Sciences Research Ethics Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention. Patients will receive standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'Smoking cessation program', 'description': 'Receives smoking cessation program', 'interventionNames': ['Other: Smoking cessation program']}], 'interventions': [{'name': 'Smoking cessation program', 'type': 'OTHER', 'otherNames': ['nicoderm', 'transdermal nicotine replacement therapy', 'nicotine replacement patch'], 'description': "Smoking cessation program includes:\n\n* brief smoking cessation counselling by preadmission nurse (less than 5 minutes)\n* smoking cessation brochures\n* referral to the Smokers' Helpline telephone advice line, run by the Canadian Cancer Society\n* free transdermal nicotine replacement therapy for 6 weeks Smokers of 10 cigarettes per day or more receive 4 weeks of nicoderm 21mg/day, 1 week of 14mg/day and 1 week of 7mg/day Smokers of less than 10 cigarettes per day receive 4 weeks of nicoderm 14mg/day and 2 weeks of 7mg/day", 'armGroupLabels': ['Smoking cessation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Philip Jones, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Philip Jones', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}