A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- Endocervical Margin Not Free of Disease.
研究概览
简要总结
The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.
SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.
详细描述
The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone . When the transformation zone contains squamous precancer and is completely ectocervical and therefore full visible, excision or destruction is an effective and relatively straightforward therapeutic entity. However in a small proportion of women a cone biopsy is necessary. A cone biopsy often requires the excision of 20-30 mms of endocervical canal.
Interventions.
- The standard procedure, LLETZ - cone (Large Loop Excision of Transformation Zone cone biopsy), is performed with a large loop electrode of 20-25 mm depth. The activated loop was applied to the cervix outside the lateral margin of transformation zone and brought slowly to the controlateral margin with the objective to acquire 20-25 mm up the canal.
- The experimental intervention is SWETZ (Straight Wire Excision of Transformation Zone), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. The activated wire was used as a knife, fashioning a cone with desired dimensions.
This technique may be able to excise the endocervical transformation zone with a lower rate of morbidity and incomplete excision rate than LLETZ cone biopsy.
The hypothesis to be tested in this trial is that SWETZ is superior to LLETZ cone in the management of endocervical pre-invasive disease.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Incompletely visible transformation zone in women with High grade Squamous Intraepithelial Lesion (HSIL)
- •Suspicion of microinvasive carcinoma or occult invasive carcinoma
- •Suspicion of glandular disease
排除标准
- •Pregnancy
- •Coagulation disorders
- •Cervicitis were present
- •Refusal to participate in the study
研究组 & 干预措施
SWETZ
The intervention administered in this arm is the straight wire excision of the transformation zone, a electrosurgical method to perform a cone biopsy using a 1 cm straight wire of 0.20 mm wire. The activated wire is used in much the same way as a cold knife or laser beam fashioning the surgical specimen to achieve two centimeters cm at cervical canal..
干预措施: Straight Wire Excision of Transformation Zone (Procedure)
LLETZ cone
The intervention administered in this arm is the large loop excision of transformation zone as a cone biopsy, performed using a large loop electrode of 2 cm depth, applied to the cervix to achieving two centimeters at cervical canal .
干预措施: Large Loop Excision of Transformation Zone (cone biopsy) (Procedure)
结局指标
主要结局
Endocervical Margin Not Free of Disease.
时间窗: 3 months after the surgery is performed.
Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.
次要结局
- Time Spent to Perform the Procedure(Time spent from randomization to complete the procedure)
研究者
MJCamargo
PHD
Oswaldo Cruz Foundation