Brief Title
LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy
Official Title
Performance of Large Loop Excision of the Transformation Zone Using Videocolposcopy Versus Binocular Colposcopy in Women With Cervical Dysplasia: a Randomized Controlled Trial.
Brief Summary
To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.
Study Type
Interventional
Primary Outcome
the resected cone mass
Secondary Outcome
Margin status
Condition
Uterine Cervical Dysplasia
Intervention
LLETZ with videocolposcope
Study Arms / Comparison Groups
LLETZ with videocolposcopy
Description: The LLETZ procedure will be performed using a videocolposcopy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
227
Start Date
March 25, 2020
Completion Date
June 29, 2021
Primary Completion Date
March 28, 2021
Eligibility Criteria
Inclusion Criteria: - histologically proven cervical dysplasia - colposcopy Prior to conization - informed consent Exclusion Criteria: - significant language barrier - a personal history of conization - pregnancy - the use of blood thinner - unwillingness to participate
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ziad Hilal, M.D., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04326049
Organization ID
CONE-5
Responsible Party
Sponsor
Study Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborators
Ruhr University of Bochum
Study Sponsor
Ziad Hilal, M.D., Principal Investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
Verification Date
July 2022