LLETZ Under Direct Colposcopic Vision

May 31, 2020 updated by: Zydolab - Institute of Cytology and Immune Cytochemistry

Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Herne, NRW, Germany, 44625
        • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LLETZ with colposcopy
The LLETZ procedure will be performed under direct colposcopic vision
Device: LLETZ with colposcopy
Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
ACTIVE_COMPARATOR: LLETZ without colposcopy
The LLETZ procedure will be performed without colposcopy
Other: LLETZ without colposcopy
Loop procedure without using a colposcope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the resected cone mass
Time Frame: 10 minutes
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Margin status
Time Frame: 2 Days after conization
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
2 Days after conization
Operation time
Time Frame: 20 minutes
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
20 minutes
Operative complications
Time Frame: 14 days
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
14 days
number of fragments of the surgical specimen
Time Frame: 10 minutes
surgeons will count the number of the surgical specimen (1 vs. >1)
10 minutes
handling of the device
Time Frame: 30 minutes
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')
30 minutes
satisfaction with the device
Time Frame: 30 minutes
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,satisfaction with the device' (ranging from 0 (,very satisfied') to 10 (,absolutely not satisfied')
30 minutes
Time to complete intraoperative hemostasis
Time Frame: 120 seconds
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
120 seconds
Intraoperative blood loss
Time Frame: 5 hours
intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively
5 hours
the dimensions of the surgical specimens
Time Frame: 2 Days after conization
The circumference, length and thickness of The surgical specimens will be measured
2 Days after conization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Collaborators

Ruhr University of Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (ESTIMATE)

September 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 31, 2020

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONE-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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