Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 24
- 主要终点
- Morbidity (Dindo Classification)
研究概览
简要总结
The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.
It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.
详细描述
This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse.
- •Patient must have provided written informed consent form prior to enrolment
- •Patient must be insured
排除标准
- •Previous of surgery for prolapse
- •Unfavourable conditions to one or other of the 2 evaluated procedure
- •Pelvic malignancy in the course of evolution
- •Contraindication to the use of mesh
- •Women not reading French
- •Patients haven't have a social insurance
- •Pregnancy or desire for future pregnancy
- •To be under guardianship or deprived of liberty
- •Simultaneous participation in another biomedical research
研究组 & 干预措施
laparoscopic sacropexy
under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.
干预措施: laparoscopic sacropexy (Procedure)
vaginal mesh
after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.
干预措施: vaginal mesh (Procedure)
结局指标
主要结局
Morbidity (Dindo Classification)
时间窗: 12 months
Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.
次要结局
- Specific complications(12 months)
- Medium-term tolerance(12 months)
- Clinical Efficiency(12 months)