Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study

We plan to recruit minimum of 1000 women referred to colposcopy in Tampere University Hospital, Helsinki University Hospital, Kuopio University Hospital, Oulu University Hospital, North Karelia Central Hospital and Hyvinkää Hospital to our prospective multi-center study. Recruitment is done at gynecology outpatient clinics of the participating units at the first colposcopy visit, where the doctor performing the colposcopy informs the eligible women about the study, gives them the patient information letter, and asks them to participate and, if they agree, to fill in the informed consent. We aim to recruit 500 women undergoing LEEP (intervention arm) and at least 500 undergoing only colposcopy (control arm).

Pirkanmaa Hospital District Ethical Review Board has approved the study design and local scientific committees in each university hospital area applied for permission to launch the study.

In each participating unit, eligible women will be given a written patient information sheet on the study and asked to participate. From women willing to participate, a written informed consent will be collected and stored in locked cabinet in participating unit. These documents will be accessed only by study members.

Participants are contacted due to the study 5 times: at the time of recruitment, 6 months after the index visit (either first colposcopy or LEEP visit) and 24 months, 3 years and 5 years after the index visit. Each time they are asked to fill in the same questionnaires, sent by mail and available also web based. No additional visits are needed, nor any extra samples taken.

The study data is collected using REDCap system designed for safe patient data management. Access to the system is strictly restricted to the research team members, that are committed to handle the data according to good clinical practice.