Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
FEMALE
NCT03764852

AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.

Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-12-04

80

Participants Needed

5

Research Sites

363 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pelvic organ prolapse is an increasingly common functional disorder which affects approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the surgical "gold standard" for the treatment of this functional disorder. It aims to suspend the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94% with low overall complication rate, evaluated at 11%. Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the future due to increasing life expectancy. 13% of women will undergo this type of procedure. The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be the benchmark for surgical activity in all eligible patients, and has expressed the need for recommendations and tools for supporting its development. The rate of outpatient surgery for prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse) in 2015 was 3.43 days. These procedures have been the subject of publications concerning outpatient care and involving low numbers of patients, with the exception of the publication by Sinhal which involved 111 patients.

CONDITIONS

Official Title

AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.

Who Can Participate

Age: 40Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman between 40 and 80 years old
  • Significant pelvic organ prolapse with POP-Q stage 2 or higher
  • Body mass index (BMI) below 30
  • ASA score 2 or less
  • Sterile urine culture (ECBU)
Not Eligible

You will not qualify if you...

  • History of pelvic cancer surgery
  • History of prolapse surgery
  • History of pelvic irradiation
  • Concomitant urethral sling placement
  • Cervico-vaginal smear test not up to date
  • Pregnant or desiring pregnancy
  • Allergy to cefazoline
  • Taking Plavix� or Vitamin K/Low Molecular Weight Heparin within 48 hours
  • Medical contraindication to outpatient care
  • Sleep apnea syndrome
  • Cardiopulmonary disease
  • Psychiatric illness
  • Bleeding risk
  • Uncontrolled diabetes
  • Uncontrolled hypertension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Hopital Antoine Beclere - Aphp

Clamart, France, 92140

Actively Recruiting

2

Chu de Nantes

Nantes, France, 44093

Actively Recruiting

3

CHU DE Nice - Hôpital l'Archet

Nice, France, 06200

Actively Recruiting

4

Ch Lyon Sud

Pierre-Bénite, France, 69310

Actively Recruiting

5

Hopital Foch

Suresnes, France, 92150

Actively Recruiting

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Research Team

B

Brannwel TIBI, MD

CONTACT

M

Matthieu DURAND, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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