Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
- Conditions
- Prolapse
- Interventions
- Other: Ambulatory surgery
- Registration Number
- NCT02926287
- Lead Sponsor
- Clinique Beau Soleil
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 157
- Age > 18 years
- Planned POP surgery
- Valid social insurance
- French spoken and written
- Informed consent signed
- No 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ambulatory surgery 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.
- Primary Outcome Measures
Name Time Method Success rate of ambulatory surgery in patient operated for urogenital prolapse After the 2 years of recruitment Success rate = (number of patients with period of hospitalization \< 12 hours)/ (number of patients operated for prolapsus)
- Secondary Outcome Measures
Name Time Method