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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervix Neoplasm; Cervix, Dysplasia
• Intervention / Treatment: Procedure: Conization with Electrosurgery diffferent power settings

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sevda Bas; Phone Number: 05300327726; Email: drsevdabas@gmail.com
• Study Contact Backup: Name: Asena Torun; Phone Number: 05324347091; Email: B.Asena.Torun@gmail.com

Study Locations

• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Recruiting
    • Adana City Training and Research Hospital
    • Contact: Sevda Bas; Phone Number: 05300327726; Email: drsevdabas@gmail.com
    • Contact: Mehtap Polat, Md; Phone Number: +5052603674; Email: drmehtap0202@gmail.com
    • Principal Investigator: Sevda Bas, Md
    • Sub-Investigator: Büşra Asena Torun, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pure Cut; Conization with Electrosurgery: Power Setting 50 watts pure cut	Procedure: Conization with Electrosurgery diffferent power settings; 50 watts pure cut,50 watts blend mode
Active Comparator: Blend; Conization with Electrosurgery:Power Setting 50 watts blend	Procedure: Conization with Electrosurgery diffferent power settings; 50 watts pure cut,50 watts blend mode
Experimental: Hybrid; Conization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife	Procedure: Conization with Electrosurgery diffferent power settings; 50 watts pure cut,50 watts blend mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days following the surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TZ evaluation	Transformation zone visibility will be evaluated during postoperative colposcopic examination and categorized as fully visible, partially visible, or not visible.	postoperative 4th month

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Sevda Bas, Universty of Health Science

Publications and helpful links

General Publications

• Prendiville W, Cullimore J, Norman S. Large loop excision of the transformation zone (LLETZ). A new method of management for women with cervical intraepithelial neoplasia. Br J Obstet Gynaecol. 1989 Sep;96(9):1054-60. doi: 10.1111/j.1471-0528.1989.tb03380.x.
• Watanabe Y, Fuchshuber P, Homma T, Bilgic E, Madani A, Hiki N, Cammack I, Noji T, Kurashima Y, Shichinohe T, Hirano S. An Unmodulated Very-Low-Voltage Electrosurgical Technology Creates Predictable and Ultimate Tissue Coagulation: From Experimental Data to Clinical Use. Surg Innov. 2020 Oct;27(5):492-498. doi: 10.1177/1553350620904610. Epub 2020 Mar 18.
• Nagar HA, Dobbs SP, McClelland HR, Price JH, McClean G, McCluggage WG. The large loop excision of the transformation zone cut or blend thermal artefact study: a randomized controlled trial. Int J Gynecol Cancer. 2004 Nov-Dec;14(6):1108-11. doi: 10.1111/j.1048-891X.2004.14608.x.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: conization
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Biopsy; Cytodiagnosis; Diagnostic Techniques, Surgical; Conization
• Other Study ID Numbers: 106751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No