Comparison of Operational Outcomes and Long-term Benefits Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Duration of hospital stay after surgery
研究概览
简要总结
Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
- •will consider TU-LESS or MPLS for myomectomy
排除标准
- •patients reluctant to long-term follow-up
结局指标
主要结局
Duration of hospital stay after surgery
时间窗: From enrollment to 1 month after receiving myomectomy
The number of days between myomectomy and the day of hospital discharge.
次要结局
- Volume of bleeding during myomectomy(From enrollment to 1 day after myomectomy.)
- Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy(From enrollment to 2 years after receiving myomectomy)
- Time between myomectomy and exhaustion(From enrollment to 1 week after myomectomy.)
- Pregnancy outcome(From enrollment to 2 years after myomectomy)
- VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy(From enrollment to 24 hours after myomectomy)
- Time of surgery(From enrollment to 1 day after myomectomy.)
- Number of uterine fibroids resected during surgery.(From enrollment to 1 day after myomectomy.)
研究者
Zheng Ying
Dean, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University
West China Second University Hospital