Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
NCT ID: NCT06078514
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-05-02
2030-12-31
Brief Summary
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The main question it aims to answer are:
* Whether LEEP affects the sexual function of women in comparison to untreated women, and
* Whether LEEP affects the health-related quality of life of women in comparison to untreated women
Participants are asked to complete web based an international validated self-report questionnaire on sexual function issues, the Female Sexual Function Index (FSFI), and a validated quality of life -questionnaire 15D at the time of first colposcopy appointment and six and 24 months, 3 years and 5 years after index visit (LEEP or first colposcopy in control group). Relevant additional background information is also collected via questionnaire and from patient files.
Researchers will compare women with LEEP and those with only colposcopy visits to see any differences between self-reported sexual function (FSFI scores) or health-related quality of life (15D scores) both short and long-term.
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Detailed Description
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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.
At the end of the study, the digital data is to be stored at Pirkanmaa Hospital Disctrict official research files, where individual patient data will be available only for identified study members. In the analysis the data will be used pseudonymized. Informed consents will be stored in participating research units.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Loop electrosurgical excision procedure (LEEP)
Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity and undergone a LEEP procedure due to HPV-related cervical lesion
Loop electrosurgical excision procedure (LEEP)
The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.
Colposcopy only
Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity with no indication to LEEP
No interventions assigned to this group
Interventions
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Loop electrosurgical excision procedure (LEEP)
The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
FEMALE
Yes
Sponsors
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Tampere University
OTHER
University of Helsinki
OTHER
Kuopio University Hospital
OTHER
Oulu University Hospital
OTHER
Hyvinkää Hospital
OTHER
North Karelia Central Hospital
OTHER
Helsinki University Central Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Laura Kotaniemi-Talonen
Deputy Chief, Gynecology and Obstetrics
Principal Investigators
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Laura Kotaniemi-Talonen, PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
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Helsinki University Central Hospital
Helsinki, , Finland
North Karelia Central Hospital
Joensuu, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Countries
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Central Contacts
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Facility Contacts
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Annu Heinonen, PhD
Role: primary
Ulla Korhonen, PhD
Role: primary
Johanna Palmroth, PhD
Role: primary
Marja Simojoki, PhD
Role: primary
Other Identifiers
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R22017
Identifier Type: -
Identifier Source: org_study_id
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