Ambulatory Prolapse Surgery
- Conditions
- Genital ProlapseVaginal Floor Prolapse
- Registration Number
- NCT02585544
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of patient with success for ambulatory surgery Day 1 (postoperative) Number of prolapse surgery patients actually managed on a day-care basis
- Secondary Outcome Measures
Name Time Method reasons for patients' refusal analysis Day 1 (before surgery) list and percentage
causes of failure of day-surgery analysis Day 1 (postoperative) list and percentage
Number of patients satisfied with day-surgery Day 1 (postoperative) pain score analysis month 1, year 1 and year 2 0 to 10 scale
quality of life scores analysis month 1, year 1 and year 2 PFIQ-7 : Pelvic Floor Impact Questionnaire
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) list and percentage
percentage dyspareunia month 1, year 1 and year 2 Post-surgery complications Day 1 (postoperative), month 1, year 1 and year 2 number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death
sexuality score analysis month 1, year 1 and year 2 PISQ-12 questionnaire
Trial Locations
- Locations (1)
Hopital Femme Mère Enfant
🇫🇷Bron, France
Hopital Femme Mère Enfant🇫🇷Bron, France