Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).
研究概览
简要总结
This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:
- Subjects will complete a 7 day pain/temperature log after surgery
- Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery
- Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction
Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).
时间窗: 1 year
次要结局
- To evaluate pain associated with the transvaginal approach (through data collection).(1 year)
研究者
Santiago Horgan
Professor of Surgery
University of California, San Diego
