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Smoking Cessation Prior to Gynecological Surgery

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ClinicalTrials.gov Identifier: NCT03942146
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Swedish National Quality Registries
The Swedish Research Council
The Swedish National Register for gynecological surgery
Information provided by (Responsible Party):
Katja Stenström Bohlin, Sahlgrenska University Hospital, Sweden

Brief Summary:
This study evaluates whether current smokers scheduled for gynecological surgery will stop smoking to a higher extent if they or the surgeon is exposed to information on smoking cessation prior to surgery in a web-based questionnaire in the Swedish National quality register for gynecological surgery, GynOp.

Condition or disease Intervention/treatment Phase
Smoking Cessation Surgery--Complications Behavioral: Information on smoking cessation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1609 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: When smoking is reported by the participant in the web-based health declaration, she is automatically randomized to one of four alternatives. The allocation ratio of randomization is 1:4 between the 4 arms: Group 1 serves as a control group and receives no specific information about smoking cessation; In Group 2 the patient receives directly the following written recommendation in the web-based health declaration "You have increased risks due to smoking. Smoking cessation 6 weeks before surgery and 6 weeks after surgery is recommended"; Group 3 The smoking status of the participant is alerted to the surgeon when filling in the preoperative form with the text " the patient smokes, recommend smoking cessation"; and Group 4, is a combination of Group 2 and 3, i.e. a written recommendation is included in the web-based health declaration as in group 2 and in addition the surgeon is alerted that the patient is a smoker and instructed to recommend smoking cessation as in group 3.
Masking: Double (Participant, Care Provider)
Masking Description: Care provider will not be informed about the study Participant is not informed about the study until the follow-up questionnaire 2 months after surgery
Primary Purpose: Prevention
Official Title: Smoking Cessation Prior to Gynecological Surgery - a Registry-based Randomized Trial
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
No information on smoking cessation
Active Comparator: Written information, GynOp
When reporting being a current smoker in the health declaration on-line the participant receives the following written recommendation in the web-based health declaration "You have increased risks due to smoking. Smoking cessation 6 weeks before surgery and 6 weeks after surgery is recommended"
Behavioral: Information on smoking cessation
Smoking cessation is recommended 6 weeks before and after surgery

Active Comparator: Doctor informed
The smoking status of the participant is alerted to the surgeon when filling in the preoperative form with the text " the patient smokes, recommend smoking cessation"
Behavioral: Information on smoking cessation
Smoking cessation is recommended 6 weeks before and after surgery

Active Comparator: Written information, GynOp + doctor informed
A combination of Group 2 and 3, i.e. a written recommendation is included in the web-based health declaration as in group 2 and in addition the surgeon is alerted that the participant is a smoker and instructed to recommend smoking cessation as in group 3.
Behavioral: Information on smoking cessation
Smoking cessation is recommended 6 weeks before and after surgery




Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: At two months after surgery ]
    Change in smoking habits measured by a questionnaire two months after surgery. The participants were asked to report their smoking habits at 6 weeks, 3-6 weeks and 1-3 weeks before surgery, the week of surgery and 1-3 weeks and 3-6 weeks after surgery. The answering alternatives were "did not smoke", "smoked less than ususal" or "smoked as usual". The rate of nonsmoking will be measured at the different time span before and after surgery.


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: Registered complications within 8 weeks after surgery ]
    The rate of minor and major complications, including infections after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   A person who is about to undergo gynecological surgery due to a gynecological disorder
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned gynecological surgery and invited to participate in GynOp
  • Current smokers
  • Ability to fill in a web-version of a questionnaire in Swedish

Exclusion Criteria:

  • Non-smokers
  • Surgery was not performed
  • No response to follow-up questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942146


Locations
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Sweden
Department of Obstetrics and gynecology
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Swedish National Quality Registries
The Swedish Research Council
The Swedish National Register for gynecological surgery
Investigators
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Principal Investigator: Katja S Bohlin, MD Department of Obstetrics and Gynecology Sahlgrenska University Hospital

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Responsible Party: Katja Stenström Bohlin, Principal Investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03942146     History of Changes
Other Study ID Numbers: Q4-15-035 E4
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study is completed and data will be described in a scientific publication within six months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katja Stenström Bohlin, Sahlgrenska University Hospital, Sweden:
Randomised registry-based trial
smoking cessation
surgery
complications