Clinical trial NCT00889720: A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery
Official title: A Multicenter, Open Label Study To Investigate The Feasibility And Efficacy Of A Smoking Cessation Program With Varenicline In Patients Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation
varenicline
elective surgery
wound infections
post-operative complications
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.

Detailed description: Recruitment to this study was terminated (on February 23, 2010) earlier than originally planned because recruitment was much slower than expected and therefore the study has already achieved its main objective of assessing the feasibility of conducting a larger study of similar design to investigate the efficacy of smoking cessation therapy in a pre-surgical setting. The decision to end recruitment to the trial was not based on any safety concerns.

Eligibility criteria: Inclusion Criteria:

* Smokers motivated to stop smoking scheduled for elective surgery

Exclusion Criteria:

* Current or recent depression
* Current or recent suicidal ideation
* Uncontrolled or unstable clinically significant medical condition

Primary outcomes:
measure: Percentage of Fully Compliant Participants
timeFrame: Baseline through Week 12
measure: Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition
timeFrame: Post-surgery Days 1-3
measure: Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition
timeFrame: Post-surgery Days 6-10
measure: Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition
timeFrame: Week 12
measure: Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition
timeFrame: Week 26
measure: Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection
timeFrame: Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26
measure: Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale
timeFrame: Post-surgery Days 1-3
measure: Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
timeFrame: Post-surgery Days 6-10
measure: Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale
timeFrame: Week 12
measure: Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale
timeFrame: Week 26
measure: Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3
timeFrame: Post-surgery Days 1-3
measure: Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10
timeFrame: Post-surgery Days 6-10
measure: Wound Healing Grade by ASEPSIS Criteria at Week 12
timeFrame: Week 12
measure: Wound Healing Grade by ASEPSIS Criteria at Week 26
timeFrame: Week 26
measure: Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.
timeFrame: 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)
Secondary outcomes:
measure: Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
timeFrame: Baseline through Week 26
measure: Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.
timeFrame: Baseline, Week 8
measure: Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)
timeFrame: Week 12
measure: Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26
timeFrame: Week 26
measure: Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.
timeFrame: Baseline, Week 12, Week 26
measure: Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
timeFrame: Baseline through Week 26 (within 30 days of last dose)
measure: Number of Treatment Emergent Adverse Events by Severity
timeFrame: Baseline through Week 26 (within 30 days of last dose)
Other outcomes:
Locations:
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: