Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization
NCT ID: NCT02515162
Last Updated: 2016-08-16
Study Results
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Basic Information
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COMPLETED
NA
178 participants
INTERVENTIONAL
2015-07-31
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fischer Cone Biopsy Excisor
Conization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor
Fischer Cone Biopsy Excisor
Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
Loop Excision Procedure
Conization Methode using a circular electrode , i.e. Loop excision Procedure
Loop Excision Procedure
Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone
Interventions
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Fischer Cone Biopsy Excisor
Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
Loop Excision Procedure
Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone
Eligibility Criteria
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Inclusion Criteria
* colposcopy Prior to conization
* informed consent
* no known hematologic disorder
Exclusion Criteria
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
18 Years
FEMALE
No
Sponsors
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Ruhr University of Bochum
OTHER
Zydolab - Institute of Cytology and Immune Cytochemistry
OTHER
Responsible Party
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Dr. med. Ziad Hilal
Dr. med. Ziad Hilal
Principal Investigators
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Ziad Hilal, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Zydolab - Institute of Cytology and Immune Cytochemistry
Locations
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Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CONE-2
Identifier Type: -
Identifier Source: org_study_id
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