Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 36
- 主要终点
- presence/absence of complications (composite score)
研究概览
简要总结
The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques.
The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.
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 (Participant)
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
- •Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery
- •The patient must have given her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 60 months of follow-up
排除标准
- •The patient is participating in another study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant
- •Patient has a stage-1 prolapse (POP-Q classification)
- •Patient has asymptomatic prolapse
- •The patient has a prolapse recurrence (i.e. this is not the first case of prolapse)
- •The patient is not available for 60 months of follow-up
- •Patient has a vaginal or urinary infection
- •Patient has poorly-adjusted diabetes
- •Patient on long-term corticotherapy
- •Patient has previously had pelvic radiotherapy
- •Patient has contraindication for anesthesia
- •Patient has an intestinal inflammatory disease
结局指标
主要结局
presence/absence of complications (composite score)
时间窗: 30 days
The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss\> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.
次要结局
- Anesthesia time (min)(1 day)
- Visual analog scale for pain(60 months)
- Surgical time (min)(1 day)
- Urodynamic exam: post-mictionnel residu (ml)(60 months)
- Time needed to prep the operation room (min)(1 day)
- Presence/absence of conversion(Day 1)
- length of hospital stay (days)(1 month)
- Presence/absence of urinary incontinence(60 months)
- Questionnaire SF36(60 months)
- Operative time (min)(1 day)
- Equipment installation time (min)(1 day)
- presence/absence of constipation(60 months)
- POP-Q score(60 months)
- Urodynamic exam, volume urinated (ml)(60 months)
- Wexner anal incontinence score(60 months)
- presence/absence of a re-intervention(30 days)
- presence/absence of dysparunia(60 months)
- Questionnaire PFDI-20(60 months)
- Questionnaire PFIQ-7(60 months)
- Questionnaire PISQ-12(60 months)
- Presence/absence of fecal incontinence(60 months)
- Urodynamic exam Q max (ml/s)(60 months)
- ODS constipation score(60 months)
- Urodynamic exam: fonctional bladder capacity (ml)(60 months)
- Urodynamic exam: urethral closure pressure (cm water)(60 months)
- Patient satisfaction(60 months)