Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms
研究概览
简要总结
Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity.
The main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons.
Our team wishes to evaluate, on a cohort of patients operated at the Caen University Hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (POP) repair by Laparoscopic Promontofixation (PFL) through symptoms and quality of life validated questionnaires (QoL).
The analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)
详细描述
This is a retrospective cohort study conducted at the Universitary hospital of Caen in three surgical departments (gynecology, urology and digestive surgery).
Patients who had a laparoscopic promontofixation will be asked to respond to validated questionnaires of symptoms and quality of life after their surgery (PFDI-20, ICIQ-SF, PFIQ-7) and satisfaction (PGI-I)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 who have had a laparoscopic promotofixation for genital prolapse at the University Hospital of Caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery.
- •Patient who received written information and agreed to participate in the study
排除标准
- •Minor patient, under guardianship, under trusteeship Patient not understanding French Refusal to participate in the study
结局指标
主要结局
Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms
时间窗: 3 years
The main objective is to collect the PFDI-20 score after the surgery. This score was developped to evaluate the genital, anorectal and digestive symptoms related to prolapse
次要结局
- Sexual impact of laparoscopic promontofixation(3 years)
- Evaluation of quality of life after prolapse surgery(3 years)
- Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone)(3 years)
- Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications(3 years)
- Effect of laparoscopic promontofixation on urinary incontinence(3 years)
- Assessment of patient satisfaction after surgery(3 years)