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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pure Cut | Active Comparator | Conization with Electrosurgery: Power Setting 50 watts pure cut |
|
| Blend | Active Comparator | Conization with Electrosurgery:Power Setting 50 watts blend |
|
| Hybrid | Experimental | Conization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conization with Electrosurgery diffferent power settings | Procedure | 50 watts pure cut,50 watts blend mode |
|
| 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 |
| 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 |
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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
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sevda Bas | Contact | 05300327726 | drsevdabas@gmail.com | |
| Asena Torun | Contact | 05324347091 | B.Asena.Torun@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sevda Bas | Universty of Health Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adana City Training and Research Hospital | Recruiting | Adana | 01060 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2804007 | Background | 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. | |
| 32186463 | Background | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019092 | Conization |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| 15571616 | Background | 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. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |