Clinical trial NCT02890017: Medico-economical Evaluation of Patient-hotel in Urology
Official title: Medico-economical Evaluation of Patient-hotel in Urology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery for Sacral Nerve Neurostimulation
Surgery for Urinary Artificial Sphincter
Surgery for Prosthetic Penile Implant
Keywords: outpatient surgery
urology medico-economic
hotel
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a medico-economic study of outpatient surgery paired with a night stay in a patient-hotel, compared with a conventional hospitalization for three types of urological surgeries.

The aim is to show that those two strategies are not different in term of adverse effects or rehospitalization, and that the patient-hotel provide a better quality of life at a reduced cost, in order to generate savings for the paying agent: the Healthcare insurance.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Healthcare insurance affiliation
* Surgeries : sacral nerve neurostimulation, urinary artificial sphincter, or prosthetic penile implant
* ASA (American Society of Anesthesiology) score between I and III
* Patients that can be accompanied by a person with a car
* Prior Informed Consent procedure form signed
* Hospitalisation in Lyon Sud Hospital

Exclusion Criteria:

* Refusal of participation or signing the consent form, guardianship or curatorship patients
* Inability to understand the procedure
* History of cognitive or psychiatric disorders
* Non eligibility to out patient
* Pregnant or breastfeeding patients
* No affiliation to Healthcare insurance

Primary outcomes:
measure: ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY)
timeFrame: at 3 months
Secondary outcomes:
measure: postoperative complications
timeFrame: at 3 months
measure: Change in general quality of life postoperatively measured by EQ5D questionnaire
timeFrame: at Baseline and after surgery at day one
measure: Change in general quality of life postoperatively measured by SF12 questionnaire
timeFrame: at Baseline and after surgery at day one
measure: Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire
timeFrame: at Baseline and at 3 moths
measure: Change in general quality of life at 3 months after surgery measured by SF12 questionnaire
timeFrame: at Baseline and at 3 moths
measure: Change in specific quality of life measured by questionnaires International Continence Society short form
timeFrame: at Baseline and after surgery at day one
measure: Change in specific quality of life measured by Post-Operative Patient questionnaire
timeFrame: at Baseline and after surgery at day one
measure: Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire
timeFrame: at Baseline and after surgery at day one
measure: Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
timeFrame: at Baseline and after surgery at day one
measure: Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
timeFrame: at Baseline and after surgery at day one
measure: Change in specific quality of life measured by International Continence Society short form
timeFrame: at Baseline and at 3 months
measure: Change in specific quality of life measured by Post-Operative Patient questionnaire
timeFrame: at Baseline and at 3 months
measure: Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire
timeFrame: at Baseline and at 3 months
measure: Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
timeFrame: at Baseline and at 3 months
measure: Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
timeFrame: at Baseline and at 3 months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Study officials:
References: