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

February 8, 2021 updated by: Clinique Beau Soleil

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Beau Soleil

Investigators

  • Principal Investigator: Christophe Courtieu, Clinique Beau Soleil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01939-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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