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Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02926287
Acronym
PCAP
Enrollment
157
Registered
2016-10-06
Start date
2015-08-31
Completion date
2018-04-30
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolapse

Keywords

prolapse surgery, ambulatory surgery

Brief summary

Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study. Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery. This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS. A randomized control study will follow PCAP study.

Detailed description

The prolapse surgery will be performed in 13% of women. Improved surgical and anesthetic techniques available makes this surgery to ambulatory care, while the latter is only slightly conducted in France. Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study. Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery. This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS. A randomized control study will follow PCAP study.

Interventions

OTHERAmbulatory surgery

All patients who accepting participation to the study and operated for prolapse surgery, Patient eligible for Ambulatory surgery and return home on the same day if delivery criteria are satisfied ( Chung criteria+tsuccessful trial of void) Patient not eligible for Ambulatory surgery are included as control group

Sponsors

Clinique Beau Soleil
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Planned POP surgery * Valid social insurance * French spoken and written * Informed consent signed * No

Design outcomes

Primary

MeasureTime frameDescription
Success rate of ambulatory surgery in patient operated for urogenital prolapseAfter the 2 years of recruitmentSuccess rate = (number of patients with period of hospitalization \< 12 hours)/ (number of patients operated for prolapsus)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026