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

Clinique Beau Soleil

Status: Completed

Conditions: Prolapse

Treatments: Other: Ambulatory surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02926287

2014-A01939-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

157 participants in 1 patient group

Ambulatory surgery

Experimental group

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.

Treatment:

Other: Ambulatory surgery