Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

August 13, 2016 updated by: Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry

Fischer Cone Biopsy Excisor Versus Loop Excision Procedure. A Randomized Trial of Two Operation Techniques in Women Undergoing Conization for Cervical Dysplasia

In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure, will be compared. The primary outcome of the study is dysplasia-free resection margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention time, postoperative pain, intra- and postoperative complications, the resected cone volume and users satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conization is the method of choice in therapy for cervical dysplasia. Beside the risk of preterm delivery, the risk of a local relapse in patients with dysplasia-affected resection margin is high.

The Goldstandard standard technique in conization for women with cervical dysplasia is the large loop excision of the transformation zone ("LLETZ"). Nevertheless other techniques such as the excision of the abnormal tissue with the so called "Fischer Cone Biopsy Excisor" could provide advantages and is yet not enough investigated. The loop excision technique uses a circular electrode, in contrast Fischer Cone Biopsy Excision is done by a triangular electrode.

It is unknown, whether the use of the circular or the triangular electrode is superior regarding the dysplasia-free resection margin rate and other outcome parameters such as the resected cone volume, postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, comparing the two electrosurgical techniques, "LLETZ-conization" and "Fischer Cone Biopsy Excision". The primary outcome of the study is the dysplasia-free resection margin rate independently proved by a pathologist, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 11 step VAS scale, time to complete hemostasis measured in seconds, duration of the intervention measured in minutes, resected cone volume, users satisfaction according to a 11 step VAS scale and intra- and postoperative complications, defined as necessity to intervene surgically up to 14 days postoperatively.

The study Population consists of women undergoing conization for histologically proven cervical dysplasia.

Study Type

Interventional

Enrollment (Actual)

178

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
  • no known hematologic disorder

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fischer Cone Biopsy Excisor
Conization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor
Procedure: Fischer Cone Biopsy Excisor
Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
Active Comparator: Loop Excision Procedure
Conization Methode using a circular electrode , i.e. Loop excision Procedure
Procedure: Loop Excision Procedure
Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Postoperative pain
Time Frame: 5 hours
patients will score their postoperative pain Level using a 11-step visual analogue scale (nVAS) and a 5-step graphical visual analogue scale (gVAS)within 5 hours after surgery
5 hours
Resected cone volume
Time Frame: 10 minutes
The resected cone volume will be measured postoperative by using a scale
10 minutes
Operative complications
Time Frame: 14 days
Operative complications defined as necessity to intervene surgically up to 14 days postoperatively
14 days

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

Investigators

  • Principal Investigator: Ziad Hilal, Dr. med., Zydolab - Institute of Cytology and Immune Cytochemistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONE-2

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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