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.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• woman between 40 and 80 years old

• Patient with significant prolapse POP-Q ≥ 2

• BMI \<30

• ASA score ≤ 2

• sterile ECBU

Locations
Other Locations
France
Hopital Antoine Beclere - Aphp
RECRUITING
Clamart
Chu de Nantes
RECRUITING
Nantes
CHU DE Nice - Hôpital l'Archet
RECRUITING
Nice
Ch Lyon Sud
RECRUITING
Pierre-bénite
Hopital Foch
RECRUITING
Suresnes
Contact Information
Primary
Brannwel TIBI, MD
tibi.b@chu-nice.fr
0492037849
Backup
Matthieu DURAND, MD
durand.m@chu-nice.fr
0492037849
Time Frame
Start Date: 2019-12-14
Estimated Completion Date: 2024-12
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov