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.

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: outpatient laparoscopic

• Registration Number: NCT03764852
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Study Start: 2019-12-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
outpatient laparoscopic	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.

Primary Outcome Measures

Name	Time	Method
Successful outpatient treatment	24 hours after surgery	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

Secondary Outcome Measures

Name	Time	Method
The percentage of failure of the outpatient	24 hours after surgery	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.

Trial Locations

Locations (5)

Hopital Antoine Beclere - Aphp; 🇫🇷 Clamart, France

Chu de Nantes; 🇫🇷 Nantes, France

CHU DE Nice - Hôpital l'Archet; 🇫🇷 Nice, France

Ch Lyon Sud; 🇫🇷 Pierre-Bénite, France

Hopital Foch; 🇫🇷 Suresnes, France