Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

NCT02926287 | Completed

• 1 other identifier: 2014-A01939-38
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prolapse

Keywords

prolapse surgery; ambulatory surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ambulatory surgery

EXPERIMENTAL

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

Interventions

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

Also known as: POQ

Ambulatory surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Planned POP surgery
• Valid social insurance
• French spoken and written
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Beau Soleil: lead

MeSH Terms

Conditions

Prolapse

Interventions

Ambulatory Surgical Procedures

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Christophe Courtieu

  Clinique Beau Soleil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: April 1, 2018
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share