NCT04358978Unknown不适用
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correction of pelvic organ prolapse
研究概览
简要总结
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
排除标准
- •Age > 75 years
- •Severe cardiovascular or respiratory disease
- •Pregnancy
结局指标
主要结局
correction of pelvic organ prolapse
时间窗: 1 year
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
次要结局
- rate of recurrence(1 year)
- long term outcomes(1 year)
研究者
Maurizio Guido
principal investigator, Director of gynaecologic and obstetric department
Catholic University of the Sacred Heart
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus FractureClosed Fracture Proximal Humerus, NeckNCT00612391Université de Montréal79
已完成
不适用
Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in TanzaniaTibial FracturesOpen Fracture of TibiaTraumaNCT03861624University of California, San Francisco240
已完成
不适用
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar FracturesSpinal DeformitySpinal FracturesSpinal InjuriesKyphosisNCT02950532AO Clinical Investigation and Publishing Documentation60
已完成
2 期
Glubran Mesh Fixation in Lichtenstein HernioplastyInguinal HerniaNCT00659542Kuopio University Hospital300
已完成
不适用
Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal ProlapseRectal ProlapseNCT05254860Azienda Ospedaliera Cardinale G. Panico50