Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Conditions
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Prolapse

Intervention / Treatment
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* Other: Ambulatory surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory surgery<br>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. | Other: Ambulatory surgery<br>* 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<br>* Other names: POQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of ambulatory surgery in patient operated for urogenital prolapse | Success rate = (number of patients with period of hospitalization < 12 hours)/ (number of patients operated for prolapsus) | After the 2 years of recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolapse surgery, ambulatory surgery