- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926287
Ambulatory Surgery for Urogenital Prolapse : a Pilot Study (PCAP)
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years
- Planned POP surgery
- Valid social insurance
- French spoken and written
- Informed consent signed
- No exclusion criteria
Exclusion Criteria:
- Refuse participation to study
- Pregnant or lactating woman
- Vulnerable people (Article L 1121-6 of the french code of public health)
- Major subject to legal protection or unable to consent (Article 1121-8 of the french code of public health )
- Participation in another protocol for less than 3 months
- Patient not presenting all the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ambulatory surgery
All the patients operated for pelvic organ prolapse during the study time will be recruited.
All the patient eligible for an Ambulatory surgery will be discharged earlier.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of ambulatory surgery in patient operated for urogenital prolapse
Time Frame: After the 2 years of recruitment
|
Success rate = (number of patients with period of hospitalization < 12 hours)/ (number of patients operated for prolapsus)
|
After the 2 years of recruitment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Courtieu, Clinique Beau Soleil
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A01939-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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