Smoking Cessation Prior to Gynecological Surgery - a Registry-based Randomized Trial

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