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.

Pelvic Organ Prolapse Clinical Trial

— AMBULAPSE  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03764852
• Other study ID #: 18-PP-12
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Brannwel TIBI, MD
• Phone: 0492037849
• Email: tibi.b[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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