LLETZ Under Direct Colposcopic Vision

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Uterine Cervical Dysplasia

Treatments: Other: LLETZ without colposcopy; Device: LLETZ with colposcopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02910388

CONE-3

Details and patient eligibility

About

To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.

Enrollment: 150 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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150 participants in 2 patient groups

LLETZ with colposcopy

Experimental group

Description:

The LLETZ procedure will be performed under direct colposcopic vision

Treatment:

Device: LLETZ with colposcopy

LLETZ without colposcopy

Active Comparator group

Description:

The LLETZ procedure will be performed without colposcopy

Treatment:

Other: LLETZ without colposcopy