Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pelvic Organ Prolapse
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 80 years
Gender
Only males

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. Succes...

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

Tracking Information

NCT #
NCT03764852
Collaborators
Not Provided
Investigators
Principal Investigator: Brannwel TIBI, MD Centre Hospitalier Universitaire de Nice