NCT01039129撤回不适用
Hybrid Transvaginal-Transabdominal Endoscopic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chronic or early appendicitis
- •Symptomatic gallstones
- •Suspicious abdominal mass/nodule
- •Age 18-60 years
- •ASA Class I or II
排除标准
- •Pregnant women
- •History of previous abdominal, pelvic, or vaginal surgery
- •History of previous abdominal or pelvic radiation therapy
- •History of fibroid uterus
- •History of endometriosis
- •History of large ovarian cyst
- •History of unexplained vaginal bleeding or dyspareunia
结局指标
主要结局
Technical success
时间窗: intra-operative
Complication
时间窗: 1 month
次要结局
- Sexual function(1 year)
- Operative time(intra-operative)
研究者
研究点 (2)
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