Ambulatory Prolapse Surgery (PROLAMBU)

Ambulatory Prolapse Surgery: Feasibility Study

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).

Study Overview

• Status: Completed
• Conditions: Genital Prolapse; Vaginal Floor Prolapse
• Intervention / Treatment: Procedure: day-care surgery

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Genital prolapse; Single arm: i.e., all patients	Procedure: day-care surgery; day-care surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient with success for ambulatory surgery	Number of prolapse surgery patients actually managed on a day-care basis	Day 1 (postoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
causes of non-eligibility for day-care management analysis	list and percentage	Day 1 (before surgery)
reasons for patients' refusal analysis	list and percentage	Day 1 (before surgery)
causes of failure of day-surgery analysis	list and percentage	Day 1 (postoperative)
Number of patients satisfied with day-surgery		Day 1 (postoperative)
Post-surgery complications	number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death	Day 1 (postoperative), month 1, year 1 and year 2
Number of prolapse correction failure		month 1, year 1 and year 2
pain score analysis	0 to 10 scale	month 1, year 1 and year 2
quality of life scores analysis	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	month 1, year 1 and year 2
quality of life scores analysis	SF- 12 Short Form (12) Health Survey	month 1, year 1 and year 2
quality of life scores analysis	PFDI-20 : Pelvic Floor Distress Inventory	month 1, year 1 and year 2
quality of life scores analysis	PGI-I : Patient Global Impression of Improvement	month 1, year 1 and year 2
quality of life scores analysis	PFIQ-7 : Pelvic Floor Impact Questionnaire	month 1, year 1 and year 2
sexuality score analysis	PISQ-12 questionnaire	month 1, year 1 and year 2
percentage dyspareunia		month 1, year 1 and year 2
number of onset of urinary incontinence		month 1, year 1 and year 2

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimated): October 23, 2015

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: day-care management; genital prolapse; vaginal route; prosthetic reinforcement
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 69HCL15_0215; 2015-A00599-40 (Other Identifier: ID-RCB)