NCT02338505Unknown2 期
Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- intraoperative complication rate
研究概览
简要总结
Phase II prospective single-institutional study.
详细描述
The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •30 ≤ BMI < 40
- •ASA < III
- •Ovarian Cyst
- •Prophylactic bilateral salpingo-oophorectomy
- •Ectopic Pregnancy
- •Pelvic Inflammatory Disease
- •Sterility/Infertility
- •Benign uterine disease (fibromatosis, adenomyosis)
- •Endometrial hiperplasia
- •Early-stage Endometrial Cancer
- •Preneoplastic lesions of the cervix
- •IA1 Cervical Cancer
- •Pelvic endometriosis
排除标准
- •Pregnancy
- •Liver disease
- •Coagulopathies
- •Clinical conditions contraindicating laparoscopy
结局指标
主要结局
intraoperative complication rate
时间窗: intraoperative
Operative time, conversion rate, estimated blood loss, visceral injury
次要结局
- postoperative complication rate(30 days)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart
研究点 (2)
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