Smoking Cessation Prior to Gynecological Surgery

NCT03942146 | Completed

• 1 other identifier: Q4-15-035 E4
• Study Type: interventional
• Target: 1,609
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Surgery--Complications

Keywords

Randomised registry-based trial; smoking cessation; surgery; complications

Outcome Measures

Primary Outcomes (1)

• Smoking cessation

  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.

  At two months after surgery

Secondary Outcomes (1)

• Postoperative complications

  Registered complications within 8 weeks after surgery

Study Arms (4)

Control group

NO INTERVENTION

No information on smoking cessation

Written information, GynOp

ACTIVE COMPARATOR

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

Doctor informed

ACTIVE COMPARATOR

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

Written information, GynOp + doctor informed

ACTIVE COMPARATOR

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

Interventions

Information on smoking cessation BEHAVIORAL

Smoking cessation is recommended 6 weeks before and after surgery

Doctor informed; Written information, GynOp; Written information, GynOp + doctor informed

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: A person who is about to undergo gynecological surgery due to a gynecological disorder
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Swedish National Quality Registries: collaborator
• The Swedish Research Council: collaborator
• The Swedish National Register for gynecological surgery: collaborator

Study Sites (1)

Department of Obstetrics and gynecology

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• Bohlin KS, Lofgren M, Lindkvist H, Milsom I. Smoking cessation prior to gynecological surgery-A registry-based randomized trial. Acta Obstet Gynecol Scand. 2020 Sep;99(9):1230-1237. doi: 10.1111/aogs.13843. Epub 2020 Apr 15.

  PMID: 32170727 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Katja S Bohlin, MD

  Department of Obstetrics and Gynecology Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 8, 2019
• Study Start: November 5, 2015
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)