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. (AMBULAPSE)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: outpatient laparoscopic; Procedure: outpatient laparoscopic

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brannwel TIBI, MD; Phone Number: 0492037849; Email: tibi.b@chu-nice.fr
• Study Contact Backup: Name: Matthieu DURAND, MD; Phone Number: 0492037849; Email: durand.m@chu-nice.fr

Study Locations

• France
  • Clamart, France, 92140
    • Recruiting
    • Hopital Antoine Beclere - Aphp
    • Contact: Xavier DEFFIEUX, MD
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Marie-Aimée PERROUIN-VERBE, MD
  • Nice, France, 06200
    • Recruiting
    • CHU de Nice - Hopital L'Archet
    • Contact: Maxence DOREZ, MD; Email: dorez.m@chu-nice.fr
  • Pierre-Bénite, France, 69310
    • Recruiting
    • CH Lyon sud
    • Contact: Alain RUFFION, MD, PhD
  • Suresnes, France, 92150
    • Recruiting
    • Hôpital Foch
    • Contact: Adrien VIDART, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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
Experimental: 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.	Procedure: outpatient laparoscopic; The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.; Procedure: outpatient laparoscopic; The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of failure of the outpatient	The percentage of failure of the outpatient is defined by the number of patients with a CHUNG score <9 in the outpatient department that does not allow the discharge of the patient or her admission to conventional hospitalization.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Brannwel TIBI, MD, Centre Hospitalier Universitaire de Nice

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: outpatient
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 18-PP-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No