Comparison of the Effects of Different Surgical Techniques on the Degree of Thermal Artifact in Patients Undergoing Conization: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Thermal Artefact
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years
- •Indication for LLETZ based on abnormal cervical cytology and/or biopsy
- •Ability to provide written informed consent -
排除标准
- •Previous cervical excisional procedure
- •Active cervical infection
- •History of cervical cancer
研究组 & 干预措施
Pure Cut
Conization with Electrosurgery: Power Setting 50 watts pure cut
干预措施: Conization with Electrosurgery diffferent power settings (Procedure)
Blend
Conization with Electrosurgery:Power Setting 50 watts blend
干预措施: Conization with Electrosurgery diffferent power settings (Procedure)
Hybrid
Conization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife
干预措施: Conization with Electrosurgery diffferent power settings (Procedure)
结局指标
主要结局
Thermal Artefact
时间窗: 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.
次要结局
- TZ evaluation(postoperative 4th month)