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PCAP: Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Sponsor
Clinique Beau Soleil (Other)
Overall Status
Completed
CT.gov ID
NCT02926287
Collaborator
(none)
157
Enrollment
1
Arm
32
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ambulatory surgery
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
157 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

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.

Other: 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 Names:
  • POQ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success rate of ambulatory surgery in patient operated for urogenital prolapse [After the 2 years of recruitment]

      Success rate = (number of patients with period of hospitalization < 12 hours)/ (number of patients operated for prolapsus)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Clinique Beau Soleil

    Investigators

    • Principal Investigator: Christophe Courtieu, Clinique Beau Soleil

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Beau Soleil
    ClinicalTrials.gov Identifier:
    NCT02926287
    Other Study ID Numbers:
    • 2014-A01939-38
    First Posted:
    Oct 6, 2016
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Clinique Beau Soleil
    prolapse surgery
    ambulatory surgery
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Feb 9, 2021