Randomized Clinical Trial Comparing Cold Knife Conization of the Cervix With and Without Lateral Hemostatic Sutures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intraoperatory vaginal bleeding
研究概览
简要总结
The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined according to the colposcopic evaluation of the patient. In case colposcopy findings are satisfactory (visible squamocolumnar junction), both ablative and excisional methods are adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the cold knife conization surgical technique to reduce blood loss. Some authors recommend that these branches should be ligated, but it remains unclear whether these sutures are actually effective in reducing bleeding.This study compared blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures.
详细描述
This is a study that will evaluate two groups of patients undergoing cold-knife conization for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures in the lateral cervical and 50% of patients will not be subjected to these sutures. The main objective of the study is to evaluate the amount of intraoperative bleeding.
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 (Participant)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •indication of cold knife conization
排除标准
- •conization using techniques other than the cold knife;
- •previous cervical conization using any other technique;
- •previous pelvic radiotherapy;
- •pregnancy; and
- •refusal to participate in the study
研究组 & 干预措施
Stitches
Cold Knife Conization with stitches
干预措施: Cold Knife Conization with stitches (Procedure)
No stitches
Cold Knife Conization without stitches
干预措施: Cold knife Conization without stitches (Procedure)
结局指标
主要结局
Intraoperatory vaginal bleeding
时间窗: Intraoperatory
The intraoperatory bleeding will be measure by weigh the gauze in grams (g).
次要结局
未报告次要终点
研究者
Ricardo dos Reis
Medical doctor
Barretos Cancer Hospital