Ambulatory Prolapse Surgery

Study Overview
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Brief Summary
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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).

Official Title
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Ambulatory Prolapse Surgery: Feasibility Study

Conditions
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Genital Prolapse, Vaginal Floor Prolapse

Intervention / Treatment
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* Procedure: day-care surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Genital prolapse<br>Single arm: i.e., all patients | Procedure: day-care surgery<br>* day-care surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with success for ambulatory surgery | Number of prolapse surgery patients actually managed on a day-care basis | Day 1 (postoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| causes of non-eligibility for day-care management analysis | list and percentage | Day 1 (before surgery) | 
| reasons for patients' refusal analysis | list and percentage | Day 1 (before surgery) | 
| causes of failure of day-surgery analysis | list and percentage | Day 1 (postoperative) | 
| Number of patients satisfied with day-surgery |  | Day 1 (postoperative) | 
| Post-surgery complications | number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death | Day 1 (postoperative), month 1, year 1 and year 2 | 
| Number of prolapse correction failure |  | month 1, year 1 and year 2 | 
| pain score analysis | 0 to 10 scale | month 1, year 1 and year 2 | 
| quality of life scores analysis | 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 | month 1, year 1 and year 2 | 
| quality of life scores analysis | SF- 12 Short Form (12) Health Survey | month 1, year 1 and year 2 | 
| quality of life scores analysis | PFDI-20 : Pelvic Floor Distress Inventory | month 1, year 1 and year 2 | 
| quality of life scores analysis | PGI-I : Patient Global Impression of Improvement | month 1, year 1 and year 2 | 
| quality of life scores analysis | PFIQ-7 : Pelvic Floor Impact Questionnaire | month 1, year 1 and year 2 | 
| sexuality score analysis | PISQ-12 questionnaire | month 1, year 1 and year 2 | 
| percentage dyspareunia |  | month 1, year 1 and year 2 | 
| number of onset of urinary incontinence |  | month 1, year 1 and year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genital prolapse, day-care management, vaginal route, prosthetic reinforcement