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Smoking Cessation Prior to Gynecological Surgery

  • Clinicaltrials.gov identifier

    NCT03942146

  • Recruitment Status

    Completed

  • First Posted

    May 8, 2019

  • Last update posted

    May 10, 2019

Study Description

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:Smoking Cessation
    Surgery--Complications
  • Intervention/Treatment: Behavioral: Information on smoking cessation
  • Phase: N/A

Detailed Description

Peri-operative smoking cessation should be introduced 4-6 weeks before surgery and continued 4-6 weeks after surgery to decrease postoperative complications. The purpose of the study is to increase the exposure to smoking cessation information pior to surgery using a web-based quality register. The hypothesis is that this will lead to an increase in perioperative smoking cessation. Women scheduled for gynecological surgery who report current smoking will be enrolled in the study. They will be randomly assigned to different sources of information about smoking cessation before surgery. The web-based Swedish national quality register for gynecological surgery, GynOp, will be utilized for randomization, obtaining information about the participant and the surgery performed as well as for follow-up. GynOp The register was established in 1997 and 90% of gynecological surgical clinics in Sweden contribute information. The conversion from paper forms to on-line registration started in 2008. When scheduled for surgery a health declaration and a questionnaire about symptoms is sent to the patients primarily via their e-mail address for direct on-line registration. This is used in 41% of the cases and the response rate has been reported to be 83%. If an e-mail address is missing, or if preferred by the patient, information is obtained by postal questionnaires (today used in 59% with a response rate of 87%). It has been previously reported that there were no differences in patient characteristics between these two means of contact except that patients without an e-mail address were slightly older and answered more frequently than patients with e-mail. The advantage of the web-based version is not only that the health declaration is sent directly to the clinic and automatically included in the medical record, but relevant information to the patient can be added in the health declaration. The on-line web-version can also be used in a randomization process, which we will utilize in this study. Data in the register is collected prospectively from patient questionnaires and doctors' forms. The patient receives written information about the register and has the opportunity to decline participation. Pre-operatively, the patient fills in a questionnaire including a health declaration with questions on comorbidity, medication and smoking status. The surgeon registers data on preoperative findings and surgical history at the enrollment before surgery. Peroperative data and events before discharge are also registered in two different forms by the surgeon. Eight weeks postoperatively the patient receives a questionnaire with questions concerning the results of the surgery and any complaints or complications. The forms are evaluated by the surgeon and data registered if there have been any complications. The randomisation process 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 will be 1:4 between the 4 arms: Group 1 serves as a control group and receives no specific information about smoking cessation Group 2 the participant 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 patient is alerted to the surgeon when filling in the preoperative form with the text " the patient smokes, recommend smoking cessation" 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. In the postoperative questionnaire two months after surgery the participant is asked to participate in a research study including questions about smoking cessation and an informed consent form will be presented and completed. Hence, she will thereby be blinded to the study when she receives the smoking cessation information in the preoperative questionnaire. The intention for this procedure is to avoid introducing any bias of being included in a study and to be able to study the effect of a recommendation in the register in a real world setting. This was accepted by the Ethics Committee and to be exposed to smoking cessation information was not considered an ethical problem as patients are routinely given written information on smoking cessation by the clinics even outside the study. The patient has the opportunity to decline participation two months after surgery when the additional questionnaire on smoking cessation is presented. Five questions on smoking cessation will be added to the ordinary postoperative questionnaire. The questions includes whether or not the woman has received smoking cessation information, from whom she has been given the information and the duration of smoking cessation in connection to surgery. These questions has gone through several phases of validation prior to study start. The randomization process in the register has also been tested thoroughly since this is the first time a randomized study is carried out in this register.

Study Design

  • Study Type: Interventional
  • 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)
  • Primary Purpose: Prevention
  • Official Title: Smoking Cessation Prior to Gynecological Surgery - a Registry-based Randomized Trial
  • Actual Study Start Date: November 2015
  • Actual Primary Completion Date: December 2017
  • Actual Study Completion Date: December 2017

Arms and interventions

Arm Intervention/treatment
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
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: 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

Outcome Measures

  • 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • 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

Contacts and Locations

Contacts

Locations

Sweden
Department of Obstetrics and gynecology
Gothenburg

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Swedish National Quality Registries

The Swedish Research Council

The Swedish National Register for gynecological surgery

Investigators

Principal Investigator: Katja S Bohlin, MD Department of Obstetrics and Gynecology Sahlgrenska University Hospital

More Information

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