Clinical trial NCT02585544: Ambulatory Prolapse Surgery
Official title: Ambulatory Prolapse Surgery: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Prolapse
Vaginal Floor Prolapse
Keywords: genital prolapse
day-care management
vaginal route
prosthetic reinforcement
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patient with success for ambulatory surgery
timeFrame: Day 1 (postoperative)
Secondary outcomes:
measure: causes of non-eligibility for day-care management analysis
timeFrame: Day 1 (before surgery)
measure: reasons for patients' refusal analysis
timeFrame: Day 1 (before surgery)
measure: causes of failure of day-surgery analysis
timeFrame: Day 1 (postoperative)
measure: Number of patients satisfied with day-surgery
timeFrame: Day 1 (postoperative)
measure: Post-surgery complications
timeFrame: Day 1 (postoperative), month 1, year 1 and year 2
measure: Number of prolapse correction failure
timeFrame: month 1, year 1 and year 2
measure: pain score analysis
timeFrame: month 1, year 1 and year 2
measure: quality of life scores analysis
timeFrame: month 1, year 1 and year 2
measure: quality of life scores analysis
timeFrame: month 1, year 1 and year 2
measure: quality of life scores analysis
timeFrame: month 1, year 1 and year 2
measure: quality of life scores analysis
timeFrame: month 1, year 1 and year 2
measure: quality of life scores analysis
timeFrame: month 1, year 1 and year 2
measure: sexuality score analysis
timeFrame: month 1, year 1 and year 2
measure: percentage dyspareunia
timeFrame: month 1, year 1 and year 2
measure: number of onset of urinary incontinence
timeFrame: month 1, year 1 and year 2
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
Study officials:
References: