Brief Title
Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization
Official Title
Fischer Cone Biopsy Excisor Versus Loop Excision Procedure. A Randomized Trial of Two Operation Techniques in Women Undergoing Conization for Cervical Dysplasia
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.
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
Primary Outcome
Margin status
Secondary Outcome
Intraoperative blood loss
Condition
Uterine Cervical Dysplasia
Intervention
Fischer Cone Biopsy Excisor
Study Arms / Comparison Groups
Fischer Cone Biopsy Excisor
Description: Conization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
178
Start Date
July 2015
Completion Date
August 2016
Primary Completion Date
July 2016
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ziad Hilal, Dr. med., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02515162
Organization ID
CONE-2
Responsible Party
Principal Investigator
Study Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborators
Ruhr University of Bochum
Study Sponsor
Ziad Hilal, Dr. med., Principal Investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
Verification Date
August 2016