LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy
Performance of Large Loop Excision of the Transformation Zone Using Videocolposcopy Versus Binocular Colposcopy in Women With Cervical Dysplasia: a Randomized Controlled Trial.
1 other identifier
interventional
227
1 country
1
Brief Summary
To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedStudy Start
First participant enrolled
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedJuly 19, 2022
July 1, 2022
1 year
March 25, 2020
July 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the resected cone mass
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
10 minutes
Secondary Outcomes (11)
Margin status
2 Days after conization
Operation time
20 minutes
Operative complications
14 days
number of fragments of the surgical specimen
10 minutes
The circumference of the surgical specimens
2 Days after conization
- +6 more secondary outcomes
Study Arms (2)
LLETZ with videocolposcopy
EXPERIMENTALThe LLETZ procedure will be performed using a videocolposcopy
LLETZ with binocular colposcopy
ACTIVE COMPARATORThe LLETZ procedure will be performed using a binocular colposcope
Interventions
Loop procedure using a videocolposcope in order to see and remove the abnormal cervical tissue
Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue
Eligibility Criteria
You may qualify if:
- histologically proven cervical dysplasia
- colposcopy Prior to conization
- informed consent
You may not qualify if:
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625, Germany
Related Publications (1)
Rezniczek GA, Neghabian N, Rehman S, Tempfer CB. Video colposcopy versus headlight for large loop excision of the transformation zone (LLETZ): a randomised trial. Arch Gynecol Obstet. 2022 Feb;305(2):415-423. doi: 10.1007/s00404-021-06331-0. Epub 2021 Nov 21.
PMID: 34802113DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Hilal, M.D.
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 30, 2020
Study Start
March 25, 2020
Primary Completion
March 28, 2021
Study Completion
June 29, 2021
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share