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Ambulatory Surgery for Urogenital Prolapse : a Pilot Study (PCAP)

Primary Purpose

Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ambulatory surgery
Sponsored by
Clinique Beau Soleil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prolapse focused on measuring prolapse surgery, ambulatory surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ambulatory surgery

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 5, 2016
    Last Updated
    February 8, 2021
    Sponsor
    Clinique Beau Soleil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02926287
    Brief Title
    Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
    Acronym
    PCAP
    Official Title
    Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    April 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clinique Beau Soleil

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prolapse
    Keywords
    prolapse surgery, ambulatory surgery

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    157 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ambulatory surgery
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Ambulatory surgery
    Other Intervention Name(s)
    POQ
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Success rate of ambulatory surgery in patient operated for urogenital prolapse
    Description
    Success rate = (number of patients with period of hospitalization < 12 hours)/ (number of patients operated for prolapsus)
    Time Frame
    After the 2 years of recruitment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christophe Courtieu
    Organizational Affiliation
    Clinique Beau Soleil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

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