Ambulatory Prolapse Surgery (PROLAMBU)

Civil Hospices of Lyon

Status: Completed

Conditions: Genital Prolapse; Vaginal Floor Prolapse

Treatments: Procedure: day-care surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02585544

69HCL15_0215

2015-A00599-40 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Genital prolapse

Other group

Description:

Single arm: i.e., all patients

Treatment:

Procedure: day-care surgery