Ambulatory Prolapse Surgery: Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of patient with success for ambulatory surgery
研究概览
简要总结
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.
Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.
The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Stage III or IV anterior genital prolapse (cystocele) on the Pelvic Organ Prolapse Quantification (POP-Q) classification and/or vaginal floor prolapse
- •Vaginal approach with prosthetic reinforcement planned
- •Patient eligible for day-surgery
- •Patient consenting to participate
- •Informed and signed consent
排除标准
- •Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, progressive disease, etc.
- •Patient with ≥1 ineligibility criterion for day-surgery
- •Impaired lower-limb range of motion preventing positioning for surgery
- •Pregnancy, ongoing or planned during the study period
- •Progressive or latent infection or signs of tissue necrosis on clinical examination
- •Non-controlled diabetes (glycated hemoglobin >8%)
- •Treatment impacting immune response (immunomodulators), ongoing or within previous month
- •History of pelvic region radiation therapy, at any time
- •History of pelvic cancer
- •Non-controlled progressive spinal pathology
- •Known hypersensitivity to one of the implant components (polypropylene)
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision.
研究组 & 干预措施
Genital prolapse
Single arm: i.e., all patients
干预措施: day-care surgery (Procedure)
结局指标
主要结局
Number of patient with success for ambulatory surgery
时间窗: Day 1 (postoperative)
Number of prolapse surgery patients actually managed on a day-care basis
次要结局
- reasons for patients' refusal analysis(Day 1 (before surgery))
- causes of failure of day-surgery analysis(Day 1 (postoperative))
- Number of patients satisfied with day-surgery(Day 1 (postoperative))
- pain score analysis(month 1, year 1 and year 2)
- Number of prolapse correction failure(month 1, year 1 and year 2)
- number of onset of urinary incontinence(month 1, year 1 and year 2)
- causes of non-eligibility for day-care management analysis(Day 1 (before surgery))
- percentage dyspareunia(month 1, year 1 and year 2)
- Post-surgery complications(Day 1 (postoperative), month 1, year 1 and year 2)
- sexuality score analysis(month 1, year 1 and year 2)
- quality of life scores analysis(month 1, year 1 and year 2)