Status:
RECRUITING
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
Tampere University
University of Helsinki
Conditions:
Cervical Dysplasia
Eligibility:
FEMALE
18-70 years
Brief Summary
The goal of this prospective study is to investigate the sexual function and quality of life of women undergoing loop electrosurgical excision procedure (LEEP) due to HPV-related cervical lesion. The...
Detailed Description
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 Centra...
Eligibility Criteria
Inclusion
- Age 18 to 70 years
- First colposcopy visit (in 24 months, if previous colposcopies)
- Referral for cytological changes or repeated HPV positivity
- No previous LEEP or other operations affecting the length of cervix
- Not pregnant at the time of colposcopy/LEEP
- Sexually active
- Capable of understanding the study protocol - informed consent given
- Fluent in Finnish
Exclusion
- Age less than 18 or more than 70 years
- Previous colposcopy within 24 months
- Referral for other reason, e.g. vulvar lesion
- Previous LEEP or other operation affecting the length of cervix
- Pregnant at the time of colposcopy/LEEP
- Sexually inactive
- Unable to understand the study protocol - no informed consent
- Difficulties in understanding Finnish
Key Trial Info
Start Date :
May 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06078514
Start Date
May 2 2024
End Date
December 1 2030
Last Update
March 20 2025
Active Locations (5)
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1
Helsinki University Central Hospital
Helsinki, Finland
2
North Karelia Central Hospital
Joensuu, Finland
3
Kuopio University Hospital
Kuopio, Finland
4
Oulu University Hospital
Oulu, Finland