search
Back to results

Ambulatory Prolapse Surgery (PROLAMBU)

Primary Purpose

Genital Prolapse, Vaginal Floor Prolapse

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
day-care surgery
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Prolapse focused on measuring genital prolapse, day-care management, vaginal route, prosthetic reinforcement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hopital Femme Mère Enfant

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Genital prolapse

Arm Description

Single arm: i.e., all patients

Outcomes

Primary Outcome Measures

Number of patient with success for ambulatory surgery
Number of prolapse surgery patients actually managed on a day-care basis

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2015
Last Updated
October 22, 2019
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT02585544
Brief Title
Ambulatory Prolapse Surgery
Acronym
PROLAMBU
Official Title
Ambulatory Prolapse Surgery: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Prolapse, Vaginal Floor Prolapse
Keywords
genital prolapse, day-care management, vaginal route, prosthetic reinforcement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genital prolapse
Arm Type
Other
Arm Description
Single arm: i.e., all patients
Intervention Type
Procedure
Intervention Name(s)
day-care surgery
Intervention Description
day-care surgery
Primary Outcome Measure Information:
Title
Number of patient with success for ambulatory surgery
Description
Number of prolapse surgery patients actually managed on a day-care basis
Time Frame
Day 1 (postoperative)
Secondary Outcome Measure Information:
Title
causes of non-eligibility for day-care management analysis
Description
list and percentage
Time Frame
Day 1 (before surgery)
Title
reasons for patients' refusal analysis
Description
list and percentage
Time Frame
Day 1 (before surgery)
Title
causes of failure of day-surgery analysis
Description
list and percentage
Time Frame
Day 1 (postoperative)
Title
Number of patients satisfied with day-surgery
Time Frame
Day 1 (postoperative)
Title
Post-surgery complications
Description
number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death
Time Frame
Day 1 (postoperative), month 1, year 1 and year 2
Title
Number of prolapse correction failure
Time Frame
month 1, year 1 and year 2
Title
pain score analysis
Description
0 to 10 scale
Time Frame
month 1, year 1 and year 2
Title
quality of life scores analysis
Description
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
Time Frame
month 1, year 1 and year 2
Title
quality of life scores analysis
Description
SF- 12 Short Form (12) Health Survey
Time Frame
month 1, year 1 and year 2
Title
quality of life scores analysis
Description
PFDI-20 : Pelvic Floor Distress Inventory
Time Frame
month 1, year 1 and year 2
Title
quality of life scores analysis
Description
PGI-I : Patient Global Impression of Improvement
Time Frame
month 1, year 1 and year 2
Title
quality of life scores analysis
Description
PFIQ-7 : Pelvic Floor Impact Questionnaire
Time Frame
month 1, year 1 and year 2
Title
sexuality score analysis
Description
PISQ-12 questionnaire
Time Frame
month 1, year 1 and year 2
Title
percentage dyspareunia
Time Frame
month 1, year 1 and year 2
Title
number of onset of urinary incontinence
Time Frame
month 1, year 1 and year 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hopital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Learn more about this trial

Ambulatory Prolapse Surgery

We'll reach out to this number within 24 hrs