Thermal Artifact in Patients Undergoing Conization: A Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSaglik Bilimleri Universitesi
About this trial
Cervical transformation zone excision is commonly used in the diagnosis and treatment of cervical intraepithelial neoplasia. Thermal artifacts can negatively affect histopathological evaluation. This study compares three different modifications of conization performed using electrosurgery in terms of the degree of thermal artifacts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Conization with Electrosurgery diffferent power settings
Procedure/Surgery50 watts pure cut,50 watts blend mode
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Pure CutActive comparator 1 intervention
Group B: BlendActive comparator 1 intervention
Group C: HybridExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Thermal Artefact
Thermal artifact will be assessed by blinded gynecologic pathologists using a structured histopathological evaluation based on epithelial distortion, coagulative necrosis, and interference with margin interpretation. Thermal artifact severity will be graded as none, mild, moderate, or severe.
Time frame
Within 7 days following the surgical procedureSecondary outcomes
1
TZ evaluation
Transformation zone visibility will be evaluated during postoperative colposcopic examination and categorized as fully visible, partially visible, or not visible.
Time frame
postoperative 4th monthSponsors and contacts
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Source ClinicalTrials.gov