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Completed

NCT Number: NCT02585544

Ambulatory Prolapse Surgery

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).

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Key information

Conditions

Genital Prolapse Vaginal Floor Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

day-care surgery

Procedure

day-care surgery

Primary outcomes

  1. Number of patient with success for ambulatory surgery

    Time frame: Day 1 (postoperative)

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

Secondary outcomes

  1. causes of non-eligibility for day-care management analysis

    Time frame: Day 1 (before surgery)

    list and percentage

  2. reasons for patients' refusal analysis

    Time frame: Day 1 (before surgery)

    list and percentage

  3. causes of failure of day-surgery analysis

    Time frame: Day 1 (postoperative)

    list and percentage

  4. Number of patients satisfied with day-surgery

    Time frame: Day 1 (postoperative)

  5. Post-surgery complications

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

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

  6. Number of prolapse correction failure

    Time frame: month 1, year 1 and year 2

  7. pain score analysis

    Time frame: month 1, year 1 and year 2

    0 to 10 scale

  8. quality of life scores analysis

    Time frame: month 1, year 1 and year 2

    SF- 12 Short Form (12) Health Survey PFDI-20 : Pelvic Floor Distress Inventory PFIQ-7 : Pelvic Floor Impact Questionnaire PGI-I : Patient Global Impression of Improvement

  9. quality of life scores analysis

    Time frame: month 1, year 1 and year 2

    SF- 12 Short Form (12) Health Survey

  10. quality of life scores analysis

    Time frame: month 1, year 1 and year 2

    PFDI-20 : Pelvic Floor Distress Inventory

  11. quality of life scores analysis

    Time frame: month 1, year 1 and year 2

    PGI-I : Patient Global Impression of Improvement

  12. quality of life scores analysis

    Time frame: month 1, year 1 and year 2

    PFIQ-7 : Pelvic Floor Impact Questionnaire

  13. sexuality score analysis

    Time frame: month 1, year 1 and year 2

    PISQ-12 questionnaire

  14. percentage dyspareunia

    Time frame: month 1, year 1 and year 2

  15. number of onset of urinary incontinence

    Time frame: month 1, year 1 and year 2

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Ambulatory Prolapse Surgery: Feasibility Study

Acronym: PROLAMBU

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2015
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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