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AzTrials

Uterine Cervical DysplasiaNCT02515162

Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

A study testing Fischer Cone Biopsy Excisor and Loop Excision Procedure in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Dysplasia
What is being tested?
Fischer Cone Biopsy Excisor and Loop Excision Procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteGermany
Study dates
Jul 2015to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically proven cervical dysplasia
  • colposcopy Prior to conization
  • informed consent
  • no known hematologic disorder

Who cannot join

  • significant language barrier
  • a personal history of conization
  • pregnancy
  • the use of blood thinner
  • unwillingness to participate

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Obstetrics and Gynecology of the Ruhr University Bochum

    Herne, North Rhine-Westphalia, 44625

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Fischer Cone Biopsy Excisor, Loop Excision Procedure
Keywords
conization, LLETZ, cervical dysplasia, cervical intraepithelial neoplasia, Fischer cone biopsy excisor, loop electrosurgical excision procedure
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fischer Cone Biopsy ExcisorProcedure or surgery

    Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone

  • Loop Excision ProcedureProcedure or surgery

    Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone

Study groups in NCT02515162
Study groupRoleWhat they receive
Fischer Cone Biopsy ExcisorExperimentalConization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor
Receives: Procedure: Fischer Cone Biopsy Excisor
Loop Excision ProcedureActive comparatorConization Methode using a circular electrode , i.e. Loop excision Procedure
Receives: Procedure: Loop Excision Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 Days after conization

Secondary outcomes (9)

  1. Intraoperative blood loss

    intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

    Measured: 5 hours

  2. Postoperative pain

    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

    Measured: 5 hours

  3. Time to complete intraoperative hemostasis

    the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

    Measured: 120 seconds

  4. 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

    Measured: 20 minutes

  5. Resected cone volume

    The resected cone volume will be measured postoperative by using a scale

    Measured: 10 minutes

  6. satisfaction with the device

    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')

    Measured: 30 minutes

  7. 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')

    Measured: 30 minutes

  8. Operative complications

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

    Measured: 14 days

  9. number of fragments of the surgical specimen

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

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02515162
Sponsor's protocol ID
CONE-2
Status last verified
Aug 2016
First submitted
28 Jul 2015
Last updated
16 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bevis KS, Biggio JR. Cervical conization and the risk of preterm delivery. Am J Obstet Gynecol. 2011 Jul;205(1):19-27. doi: 10.1016/j.ajog.2011.01.003. Epub 2011 Feb 23.

    PubMed 21345402

  • Jin G, LanLan Z, Li C, Dan Z. Pregnancy outcome following loop electrosurgical excision procedure (LEEP) a systematic review and meta-analysis. Arch Gynecol Obstet. 2014 Jan;289(1):85-99. doi: 10.1007/s00404-013-2955-0. Epub 2013 Jul 11.

    PubMed 23843155

  • Khalid S, Dimitriou E, Conroy R, Paraskevaidis E, Kyrgiou M, Harrity C, Arbyn M, Prendiville W. The thickness and volume of LLETZ specimens can predict the relative risk of pregnancy-related morbidity. BJOG. 2012 May;119(6):685-91. doi: 10.1111/j.1471-0528.2011.03252.x. Epub 2012 Feb 14.

    PubMed 22329499

  • Shaco-Levy R, Eger G, Dreiher J, Benharroch D, Meirovitz M. Positive margin status in uterine cervix cone specimens is associated with persistent/recurrent high-grade dysplasia. Int J Gynecol Pathol. 2014 Jan;33(1):83-8. doi: 10.1097/PGP.0b013e3182763158.

    PubMed 24300540

  • Mathevet P, Chemali E, Roy M, Dargent D. Long-term outcome of a randomized study comparing three techniques of conization: cold knife, laser, and LEEP. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):214-8. doi: 10.1016/s0301-2115(02)00245-2.

    PubMed 12551795

  • Boardman LA, Steinhoff MM, Shackelton R, Weitzen S, Crowthers L. A randomized trial of the Fischer cone biopsy excisor and loop electrosurgical excision procedure. Obstet Gynecol. 2004 Oct;104(4):745-50. doi: 10.1097/01.AOG.0000139517.26003.fc.

    PubMed 15458896

Questions about this trial

What is this clinical trial studying?

A study testing Fischer Cone Biopsy Excisor and Loop Excision Procedure in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Margin status (time frame: 2 Days after conization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02515162, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.

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