Brief Title
LLETZ Under General Versus Local Anesthesia
Official Title
Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
Brief Summary
The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.
Study Type
Interventional
Primary Outcome
Womens satisfaction
Secondary Outcome
Postoperative pain
Condition
Uterine Cervical Dysplasia
Intervention
LLETZ under local anaesthesia
Study Arms / Comparison Groups
LLETZ under local anaesthesia
Description: The LLETZ procedure will be performed under local anaesthesia
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
Procedure
Estimated Enrollment
229
Start Date
April 3, 2018
Completion Date
March 14, 2020
Primary Completion Date
February 28, 2020
Eligibility Criteria
Inclusion Criteria: - colposcopy Prior to conization - informed consent - histologically proven high grade cervical dysplasia - Transformation zone typ 1 or 2 Exclusion Criteria: - significant language barrier - a personal history of conization - pregnancy - the use of blood thinner - unwillingness to participate - oncological disease - inpatient treatment - women who are not fasting - risk of aspiration - columnar-squamous epithelium border not fully visible
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
NCT03494686
Organization ID
CONE-4
Responsible Party
Sponsor
Study Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Sponsor
Ziad Hilal, M.D., Principal Investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
Verification Date
March 2020