Multicenter Study on the Correction of Prolapse Via Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Pelvic Organ Prolapse Distress Inventory
研究概览
简要总结
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
详细描述
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.
排除标准
- •History of abdominal prolapse reconstructive surgery.
- •History of prolapse reconstructive surgery with vaginal meshes.
- •Stage I according to the POP-Q classification or asymptomatic prolapse.
- •Medical contraindication for general anaesthesia.
- •Patient preference for vaginal surgical treatment.
- •Patient does not wish to participate in the study.
研究组 & 干预措施
lateral laparoscopic suspension (LLS)
干预措施: lateral laparoscopic suspension (LLS) (Procedure)
Sacropexy without posterior mesh fixation on the puborrectalis muscle
干预措施: Sacropexy without posterior mesh fixation on the puborrectalis muscle (Procedure)
结局指标
主要结局
Pelvic Organ Prolapse Distress Inventory
时间窗: up to 12 months
Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6
Colorectal-Anal Distress Inventory
时间窗: up to 12 months
Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8
Number of patients with symptomatic failure
时间窗: up to 12 months
Number of patients with symptomatic failure , defined as a positive response (accompanied by any degree of discomfort) to the following question on the validated questionnaire regarding prolapse symptoms (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"
Urinary Distress Inventory
时间窗: up to 12 months
Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.
次要结局
- Intestinal and pain symptoms(up to 12 months)
- Anatomical result(up to 12 months)