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.

NCT ID: NCT03764852

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-14
• Study Completion Date: 2026-12-31

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.

Detailed Description

In our study, the investigators propose to evaluate the success rate for outpatient laparoscopic sacrocolpopexy with or without robotic assistance in screened patients. With this aim in mind, the investigators will conduct a national multicenter prospective study including 80 female patients. 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. The outpatient success rate for other surgical techniques such as cholecystectomy or laparoscopic hysterectomy is above 90% in the literature. Envisaging an equivalent rate after laparoscopic sacrocolpopexy, our population size would make it possible to obtain precision +/- 5.3% for estimation of this proportion. The patients are followed up for 1 month with a postoperative visit at 30 days, during which the efficacy of the technique is evaluated using conventional indicators (POP-Q; ICIQ, USP, PFDI-20, PISQ-12, PFIQ-7, etc.). Once completed, this preliminary investigation will make it possible to define a reference value for successful outpatient sacrocolpopexy, which has not yet been published, which may be used as a basis for a larger scale randomized study that would aim to compare the efficacy of outpatient treatment, with conventional inpatient treatment, for efficient patient management

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

outpatient laparoscopic

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.

Group Type: EXPERIMENTAL

outpatient laparoscopic

Intervention Type: PROCEDURE

The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.

outpatient laparoscopic

Intervention Type: PROCEDURE

The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.

Interventions

outpatient laparoscopic

The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.

Intervention Type: PROCEDURE

outpatient laparoscopic

The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Psychiatric pathology
• Hemorrhagic risk
• Diabetes imbalanced
• Unbalanced Hypertension

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brannwel TIBI, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Hopital Antoine Beclere - Aphp

Clamart, , France

Site Status: RECRUITING

Chu de Nantes

Nantes, , France

Site Status: RECRUITING

CHU DE Nice - Hôpital l'Archet

Nice, , France

Site Status: RECRUITING

Ch Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

Hopital Foch

Suresnes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Brannwel TIBI, MD

Role: CONTACT

tibi.b@chu-nice.fr

0492037849

Matthieu DURAND, MD

Role: CONTACT

durand.m@chu-nice.fr

0492037849

Facility Contacts

Xavier DEFFIEUX, MD

Role: primary

Marie-Aimée PERROUIN-VERBE, MD

Role: primary

Maxence DOREZ, MD

Role: primary

dorez.m@chu-nice.fr

Alain RUFFION, MD, PhD

Role: primary

Adrien VIDART, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 24365629 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9921553 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17370026 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23721700 (View on PubMed)

Other Identifiers

18-PP-12

Identifier Type: -

Identifier Source: org_study_id