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