Brief Title
LLETZ Under Direct Colposcopic Vision
Official Title
Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.
Brief Summary
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
Study Type
Interventional
Primary Outcome
the resected cone mass
Secondary Outcome
Margin status
Condition
Uterine Cervical Dysplasia
Intervention
LLETZ with colposcopy
Study Arms / Comparison Groups
LLETZ with colposcopy
Description: The LLETZ procedure will be performed under direct colposcopic vision
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
150
Start Date
October 2016
Completion Date
December 2017
Primary Completion Date
December 2017
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
NCT02910388
Organization ID
CONE-3
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
December 2017