Ambulatory Prolapse Surgery

Not Applicable

Completed

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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Genital prolapse	day-care surgery	Single arm: i.e., all patients

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
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
percentage dyspareunia	month 1, year 1 and year 2

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