LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Uterine Cervical Dysplasia

Treatments: Device: LLETZ with videocolposcope; Device: LLETZ with binocular colposcope

Study type: Interventional

Funder types: Other

Identifiers

NCT04326049

CONE-5

Details and patient eligibility

About

To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.

Enrollment: 227 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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227 participants in 2 patient groups

LLETZ with videocolposcopy

Experimental group

Description:

The LLETZ procedure will be performed using a videocolposcopy

Treatment:

Device: LLETZ with videocolposcope

LLETZ with binocular colposcopy

Active Comparator group

Description:

The LLETZ procedure will be performed using a binocular colposcope

Treatment:

Device: LLETZ with binocular colposcope