Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

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.

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Key information

Conditions

Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambulatory surgery

Other

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

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Clinique Beau Soleil

Other

Registry information

Acronym: PCAP

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2018
First posted: Oct 6, 2016
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed