NCT00676325Unknown4 期
A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .
Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The primary outcome measure is recurrent anterior vaginal prolapse
研究概览
简要总结
A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.
详细描述
Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.
排除标准
- •Patients were excluded if they had:
- •Stage 0 or I (ics96) anterior vaginal support
- •Declined participation
- •Were pregnant or contemplating future pregnancy
- •Had prior anterior vaginal prolapse repair with biologic or synthetic graft
- •Active or latent systemic infection
- •Compromised immune system
- •Uncontrolled diabetes mellitus,
- •Previous pelvic irradiation or cancer
- •Known hypersensitivity to polypropylene.
结局指标
主要结局
The primary outcome measure is recurrent anterior vaginal prolapse
时间窗: 1 year
次要结局
- Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia .(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine DermisAnterior Vaginal Wall ProlapseCystocelePelvic Organ ProlapseNCT01393171Kaiser Permanente99
Unknown
不适用
Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall HerniasVentral HerniaVentral Incisional HerniaUmbilical HerniaNCT03255239Hôpital Universitaire Taher Sfar120
Unknown
不适用
Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh RepairHernia, InguinalHernia DirectHernias IndirectQuality of LifeNCT04149847Edward Amoah Boateng158
已完成
不适用
Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting SystemDental ImplantsAlveolar Ridge PreservationNCT02702609Sunstar Americas45
已完成
不适用
Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back PainLow Back PainNCT02883569Seoul National University Hospital1,102