Skip to content

Thermal Artifact in Patients Undergoing Conization: A Clinical Study

Comparison of the Effects of Different Surgical Techniques on the Degree of Thermal Artifact in Patients Undergoing Conization: A Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07372248
Enrollment
150
Registered
2026-01-28
Start date
2026-02-23
Completion date
2026-12-30
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix, Dysplasia, Cervix Neoplasm

Keywords

conization

Brief summary

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.

Detailed description

Conization procedures performed using electrosurgical techniques, such as LEEP, NETZ, and SWETZ, are well described in the literature. Compared with cold knife conization, these methods offer several advantages, including the ability to be performed under local anesthesia, shorter procedure time, and lower cost. However, electrosurgical techniques may compromise histopathological evaluation of surgical specimens due to the presence of thermal artifacts, which can obscure tissue architecture and surgical margins. In our clinic, conization procedures are routinely performed using a hybrid technique that combines electrosurgery with cold knife conization. This study aims to compare three different modifications of this hybrid technique applied in our institution with respect to the degree of thermal artifact formation and the quality of surgical margin evaluation.

Interventions

PROCEDUREConization with Electrosurgery diffferent power settings

50 watts pure cut,50 watts blend mode

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Women aged ≥18 years Indication for LLETZ based on abnormal cervical cytology and/or biopsy Ability to provide written informed consent -

Exclusion criteria

Previous cervical excisional procedure Pregnancy Active cervical infection History of cervical cancer \-

Design outcomes

Primary

MeasureTime frameDescription
Thermal ArtefactWithin 7 days following the surgical procedureThermal 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.

Secondary

MeasureTime frameDescription
TZ evaluationpostoperative 4th monthTransformation zone visibility will be evaluated during postoperative colposcopic examination and categorized as fully visible, partially visible, or not visible.

Countries

Turkey (Türkiye)

Contacts

CONTACTSevda Bas
drsevdabas@gmail.com05300327726
CONTACTAsena Torun
B.Asena.Torun@gmail.com05324347091
PRINCIPAL_INVESTIGATORSevda Bas

Universty of Health Science

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026