LLETZ Under Direct Colposcopic Vision

N/ACompletedNCT02910388

Zydolab - Institute of Cytology and Immune Cytochemistry150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Uterine Cervical Dysplasia

Interventions

LLETZ with colposcopyDEVICE

Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue

LLETZ without colposcopyOTHER

Loop procedure without using a colposcope

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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

Time frame: 10 minutes

Secondary Outcomes

Margin status

Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist

Time frame: 2 Days after conization

Operation time

the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes

Time frame: 20 minutes

Operative complications

Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

Time frame: 14 days

number of fragments of the surgical specimen

surgeons will count the number of the surgical specimen (1 vs. \>1)

Time frame: 10 minutes

the dimensions of the surgical specimens

The circumference, length and thickness of The surgical specimens will be measured

Time frame: 2 Days after conization

handling of the device

surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,(ranging from 0 (,very easy') to 10 (,very difficult')

Data from ClinicalTrials.gov

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