Genital Prolapse, Vaginal Floor Prolapse
Conditions
Keywords
genital prolapse, day-care management, vaginal route, prosthetic reinforcement
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).
Interventions
PROCEDUREday-care surgery
day-care surgery
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with success for ambulatory surgery | Day 1 (postoperative) | Number of prolapse surgery patients actually managed on a day-care basis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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 |
| Number of prolapse correction failure | month 1, year 1 and year 2 | — |
| causes of non-eligibility for day-care management analysis | Day 1 (before surgery) | list and percentage |
| quality of life scores analysis | month 1, year 1 and year 2 | SF- 12 Short Form (12) Health Survey PFDI-20 : Pelvic Floor Distress Inventory PFIQ-7 : Pelvic Floor Impact Questionnaire PGI-I : Patient Global Impression of Improvement |
| sexuality score analysis | month 1, year 1 and year 2 | PISQ-12 questionnaire |
| percentage dyspareunia | month 1, year 1 and year 2 | — |
| number of onset of urinary incontinence | month 1, year 1 and year 2 | — |
| pain score analysis | month 1, year 1 and year 2 | 0 to 10 scale |
Countries
France
Outcome results
None listed