Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Containment bag integrity
研究概览
简要总结
This study evaluates the feasibility, safety, and efficiency of transvaginal in-bag electromechanical morcellation for specimen extraction in patients undergoing total laparoscopic hysterectomy for large uteri.
详细描述
This single-center prospective study investigates a novel transvaginal specimen extraction technique using a sealed containment bag combined with electromechanical morcellation. The procedure aims to improve specimen extraction efficiency while preventing tissue dissemination during laparoscopic hysterectomy for uteri larger than 12-week gestational size.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 38 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 38 to 52 years
- •Planned to undergo total laparoscopic hysterectomy
- •Uterine size greater than 12 weeks gestational size based on preoperative imaging
- •Eligible for transvaginal specimen extraction
- •Able and willing to provide written informed consent
排除标准
- •Advanced gynecologic malignancy
- •Severe pelvic obliteration preventing transvaginal access
- •Contraindication to laparoscopic surgery
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
Containment bag integrity
时间窗: Immediately after specimen extraction
Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction
次要结局
- Specimen extraction time(Periprocedurally)
- Total operative time(Immediately after surgery)
- Estimated intraoperative blood loss(During surgery)
- Postoperative complications(Up to 30 days postoperatively)
- Length of postoperative hospital stay(Up to 7 days postoperatively)
研究者
Chang Zhou
Doctor of Obstetrics and Gynecology
China-Japan Friendship Hospital