Prospective Study of the Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- improvement of symptoms
研究概览
简要总结
Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue.
Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study.
The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •women over 18
- •middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring surgical correction of stage ≥ II in the POP-Q classification
- •patients wanting an intervention because of the discomfort caused by the prolapse
- •intervention planned by anterior sacrospinofixation by autologous tissues
- •person having expressed his non-opposition
排除标准
- •prolapse of stage < II in the POP-Q classification, or prolapse without functional impairment
- •disorders involving an unacceptable risk of postoperative complications sought after questioning of the patient (blood coagulation disorders, immune system disorders, progressive diseases, etc.)
- •reduced mobility of the lower limbs (not allowing positioning for surgery)
- •pregnancy or any pregnancy plan for the duration of the study
- •active or latent infection
- •inability to understand the information given
- •person deprived of liberty, under guardianship.
研究组 & 干预措施
anterior sacrospinofixation with autologous tissue
patients with middle and / or anterior prolapse ≥ II in the POP-Q classification and for whom an intervention by anterior sacrospinofixation by autologous tissues is planned.
干预措施: evolution of patient symptoms (Other)
结局指标
主要结局
improvement of symptoms
时间窗: at Month 2
percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3)
次要结局
未报告次要终点