Thermal Artifact in Patients Undergoing Conization: A Clinical Study

Saglik Bilimleri Universitesi

Status: Not yet enrolling

Conditions: Cervix Neoplasm; Cervix, Dysplasia

Treatments: Procedure: Conization with Electrosurgery diffferent power settings

Study type: Interventional

Funder types: Other

Identifiers

NCT07372248

106751

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Pure Cut

Active Comparator group

Description:

Conization with Electrosurgery: Power Setting 50 watts pure cut

Treatment:

Procedure: Conization with Electrosurgery diffferent power settings

Blend

Active Comparator group

Description:

Conization with Electrosurgery:Power Setting 50 watts blend

Treatment:

Procedure: Conization with Electrosurgery diffferent power settings

Hybrid

Experimental group

Description:

Conization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife

Treatment:

Procedure: Conization with Electrosurgery diffferent power settings