NCT02248935已完成不适用
Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh
排除标准
- •Refusal to participate in our long-term outcome study
结局指标
主要结局
Clinical Cure Rate
时间窗: 5-6 years
To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire
次要结局
- Surgical Satisfaction(5-6 years)
- Objective Anatomic Outcome(5-6 year)
- Mesh exposure/erosion(5-6 years)
- Symptom Comparison(5-6 years)
- Complications(5-6 years)
研究者
研究点 (1)
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