Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization
1 other identifier
interventional
178
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
August 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 16, 2016
August 1, 2016
1 year
July 28, 2015
August 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
2 Days after conization
Secondary Outcomes (9)
Intraoperative blood loss
5 hours
Postoperative pain
5 hours
Time to complete intraoperative hemostasis
120 seconds
Operation time
20 minutes
Resected cone volume
10 minutes
- +4 more secondary outcomes
Study Arms (2)
Fischer Cone Biopsy Excisor
EXPERIMENTALConization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor
Loop Excision Procedure
ACTIVE COMPARATORConization Methode using a circular electrode , i.e. Loop excision Procedure
Interventions
Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone
Eligibility Criteria
You may qualify if:
- histologically proven cervical dysplasia
- colposcopy Prior to conization
- informed consent
- no known hematologic disorder
You may not qualify if:
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625, Germany
Related Publications (6)
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.
PMID: 21345402BACKGROUNDJin 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.
PMID: 23843155BACKGROUNDKhalid 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.
PMID: 22329499BACKGROUNDShaco-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.
PMID: 24300540BACKGROUNDMathevet 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.
PMID: 12551795BACKGROUNDBoardman 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.
PMID: 15458896BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Hilal, Dr. med.
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Ziad Hilal
Study Record Dates
First Submitted
July 28, 2015
First Posted
August 4, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
August 16, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share