Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
NCT ID: NCT02926287
Last Updated: 2021-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2015-08-31
2018-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Ambulatory 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
Interventions
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Ambulatory 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned POP surgery
* Valid social insurance
* French spoken and written
* Informed consent signed
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Clinique Beau Soleil
OTHER
Responsible Party
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Principal Investigators
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Christophe Courtieu
Role: PRINCIPAL_INVESTIGATOR
Clinique Beau Soleil
Other Identifiers
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2014-A01939-38
Identifier Type: -
Identifier Source: org_study_id
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