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NCT02926287 Clinical Trial

Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Prolapse Clinical Trial

— PCAP  

Official title:
Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02926287
Other study ID # 2014-A01939-38
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date April 2018

Study information
Verified date February 2021
Source Clinique Beau Soleil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 157
Est. completion date April 2018
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Clinique Beau Soleil

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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