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.

NCT03764852 | Recruiting

• 1 other identifier: 18-PP-12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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

Pelvic Organ Prolapse

Keywords

outpatient

Outcome Measures

Primary Outcomes (1)

• Successful outpatient treatment

  Successful outpatient treatment is defined by the absence of conventional inpatient admission with 24H after surgery, the indications for admission being a CHUNG Score \< 9, one perioperative complication, postoperative urinary retention requiring reinsertion of a urinary catheter

  24 hours after surgery

Secondary Outcomes (1)

• The percentage of failure of the outpatient

  24 hours after surgery

Study Arms (1)

outpatient laparoscopic

EXPERIMENTAL

Patients will have laparoscopic outpatients. The procedure is identical to that performed in hospital. What changes is that the patient will return home at night if her condition allows it.

Procedure: outpatient laparoscopic

Interventions

outpatient laparoscopic PROCEDURE

The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.

outpatient laparoscopic

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Only woman with pelvic organ prolapse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• woman between 40 and 80 years old
• Patient with significant prolapse POP-Q ≥ 2
• BMI \<30
• ASA score ≤ 2
• sterile ECBU

You may not qualify if:

• Criteria related to the pathology or the organ:
• History of pelvic cancer surgery
• History of prolapse surgery
• History of pelvic irradiation
• Laying a concomitant urethral strip
• Cervico-vaginal smear test not up to date.
• Patient pregnant or having a desire for pregnancy
• Criteria related to concomitant treatments:
• Cefazoline allergy
• Taking the following medications within 48 hours
• Plavix®
• Vitamin K / Low Molecular Weight Healing Heparin
• Contraindication to ambulatory care for medical reasons
• Sleep apnea syndrome
• Cardiopulmonary pathology

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (5)

Hopital Antoine Beclere - Aphp

Clamart, 92140, France

RECRUITING

Chu de Nantes

Nantes, 44093, France

RECRUITING

CHU DE Nice - Hôpital l'Archet

Nice, 06200, France

RECRUITING

Ch Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Hopital Foch

Suresnes, 92150, France

RECRUITING

Related Publications (4)

• Drapier E, De Poncheville L, Dannappel T, Clerc P, Smirnoff A. [Day case laparoscopic sacral colpopexy for genital prolapse]. Prog Urol. 2014 Jan;24(1):51-6. doi: 10.1016/j.purol.2013.07.007. Epub 2013 Aug 13. French.

  PMID: 24365629 BACKGROUND

• Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. doi: 10.1016/s0889-8545(05)70039-5.

  PMID: 9921553 BACKGROUND

• Flam F. Sedation and local anaesthesia for vaginal pelvic floor repair of genital prolapse using mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec;18(12):1471-5. doi: 10.1007/s00192-007-0350-8. Epub 2007 Mar 17.

  PMID: 17370026 RESULT

• Cuvelier G. [The ambulatory surgery, source of publications]. Prog Urol. 2013 Jun;23(7):427-9. doi: 10.1016/j.purol.2013.02.007. Epub 2013 Mar 26. No abstract available. French.

  PMID: 23721700 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Brannwel TIBI, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brannwel TIBI, MD

CONTACT

0492037849; tibi.b@chu-nice.fr

Matthieu DURAND, MD

CONTACT

0492037849; durand.m@chu-nice.fr

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: December 3, 2018
• First Posted: December 5, 2018
• Study Start: December 14, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)