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NCT Number: NCT07372248

Thermal Artifact in Patients Undergoing Conization: A Clinical Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adana City Training and Research Hospital

Adana, 01060, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Asena Torun, Md

SUB_INVESTIGATOR

Mehtap Polat, Md

CONTACT

[email protected]

+5052603674

Sevda Bas

CONTACT

[email protected]

05300327726

Sevda Bas, Md

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Conization with Electrosurgery diffferent power settings

Procedure

50 watts pure cut,50 watts blend mode

Primary outcomes

  1. Thermal Artefact

    Time frame: Within 7 days following the surgical procedure

    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.

Secondary outcomes

  1. TZ evaluation

    Time frame: postoperative 4th month

    Transformation zone visibility will be evaluated during postoperative colposcopic examination and categorized as fully visible, partially visible, or not visible.

Study contacts

Contact information is provided by the study sponsor or research team.

Asena Torun

CONTACT

[email protected]

05324347091

Sevda Bas

CONTACT

[email protected]

05300327726

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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