Ambulatory Prolapse Surgery

Hospices Civils de Lyon38 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Genital Prolapse Vaginal Floor Prolapse

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of patient with success for ambulatory surgery

Number of prolapse surgery patients actually managed on a day-care basis

Time frame: Day 1 (postoperative)

Secondary Outcomes

causes of non-eligibility for day-care management analysis

list and percentage

Time frame: Day 1 (before surgery)

reasons for patients' refusal analysis

list and percentage

Time frame: Day 1 (before surgery)

causes of failure of day-surgery analysis

list and percentage

Time frame: Day 1 (postoperative)

Number of patients satisfied with day-surgery

Time frame: Day 1 (postoperative)

Post-surgery complications

number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death

Time frame: Day 1 (postoperative), month 1, year 1 and year 2

Number of prolapse correction failure