Ambulatory Prolapse Surgery

NCT ID: NCT02585544

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-15
• Study Completion Date: 2019-09-03

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).

Conditions

Genital Prolapse; Vaginal Floor Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genital prolapse

Single arm: i.e., all patients

Group Type: OTHER

day-care surgery

Intervention Type: PROCEDURE

day-care surgery

Interventions

day-care surgery

day-care surgery

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Femme Mère Enfant

Bron, , France

Countries

France

References

Lamblin G, Courtieu C, Bensouda-Miguet C, Panel L, Moret S, Chabert P, Chene G, Nohuz E. Outpatient vaginal surgery for pelvic organ prolapse: a prospective feasibility study. Minerva Ginecol. 2020 Feb;72(1):19-24. doi: 10.23736/S0026-4784.20.04510-4.

Reference Type: BACKGROUND

PMID: 32153159 (View on PubMed)

Other Identifiers

2015-A00599-40

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL15_0215

Identifier Type: -

Identifier Source: org_study_id