The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair.
研究概览
简要总结
Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation.
In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.
详细描述
All patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. These patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op.
After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all healthy patients with genital prolapse grade 3-4, going for vaginal surgery
- •age 30-80years
排除标准
- •patients with pelvic inflammatory disease
- •patients after pelvic irradiation
- •large vaginal erosion
- •vaginal bleeding uncontrolled or undiagnosed
- •patients going for surgery with mesh
结局指标
主要结局
Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair.
时间窗: 24 month
The investigators hope to see a low percentage of prolapse recurrence in the study (pessary) group, comparing to the control (no pessary) group
次要结局
未报告次要终点
研究者
Klein zvi
Head of urogynecology unit
Meir Medical Center