NCT02585544

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3.9 years

First QC Date

October 19, 2015

Last Update Submit

August 27, 2025

Conditions

Genital ProlapseVaginal Floor Prolapse

Keywords

genital prolapseday-care managementvaginal routeprosthetic reinforcement

Outcome Measures

Primary Outcomes (1)

  • Number of patient with success for ambulatory surgery

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

    Day 1 (postoperative)

Secondary Outcomes (15)

  • causes of non-eligibility for day-care management analysis

    Day 1 (before surgery)

  • reasons for patients' refusal analysis

    Day 1 (before surgery)

  • causes of failure of day-surgery analysis

    Day 1 (postoperative)

  • Number of patients satisfied with day-surgery

    Day 1 (postoperative)

  • Post-surgery complications

    Day 1 (postoperative), month 1, year 1 and year 2

  • +10 more secondary outcomes

Study Arms (1)

Genital prolapse

OTHER

Single arm: i.e., all patients

Procedure: day-care surgery

Interventions

day-care surgeryPROCEDURE

day-care surgery

Genital prolapse

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Femme Mère Enfant

Bron, 69500, France

Location

Related Publications (1)

  • 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.

    PMID: 32153159BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 23, 2015

Study Start

October 15, 2015

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations

FR(1)