Medico-economical Evaluation of Patient-hotel in Urology

Study Overview
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Brief Summary
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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.

Official Title
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Medico-economical Evaluation of Patient-hotel in Urology

Conditions
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Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter, Surgery for Prosthetic Penile Implant

Intervention / Treatment
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* Other: postoperative hotel
* Other: conventional hospitalization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hotel-Ambu<br>Outpatient surgery with a patient-hotel night | Other: postoperative hotel<br>* Outpatient surgery First night stay in a defined patient-hotel Patient come for consultation the next morning of surgery to remove the catheter and/or the compressive bandage. The absence of adverse events is checked, the discharge is confirmed and the evaluation questionnaire is given to the patient. Postoperative consultation at 1 and 3 months.<br>|
| Other: conventional hospitalization<br>conventional hospitalization | Other: conventional hospitalization<br>* Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY) | Efficacity (QALY) is a composite measure of quality of life and adverse events occurence: Quality of life is a composite score of : EQS5D questionnaire converted in utility, Other questionnaires : SF-12 ; International Continence Society short form, Post-Operative Patient, Global Impression of Improvement (PGI-I), l'Incontinence Impact Questionnaire-Short Form (IIQ-SF) et l'Urogenital Distress Index (UDI-SF). Adverse events occurrence : urinary retention, postoperative infection, rehospitalization Costs : according to  micro-costing  method. Rehospitalizations will be priced from ENC rate. | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | All postoperative complications that occur within 3 months | at 3 months | 
| Change in general quality of life postoperatively measured by EQ5D questionnaire |  | at Baseline and after surgery at day one | 
| Change in general quality of life postoperatively measured by SF12 questionnaire |  | at Baseline and after surgery at day one | 
| Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire |  | at Baseline and at 3 moths | 
| Change in general quality of life at 3 months after surgery measured by SF12 questionnaire |  | at Baseline and at 3 moths | 
| Change in specific quality of life measured by questionnaires International Continence Society short form |  | at Baseline and after surgery at day one | 
| Change in specific quality of life measured by Post-Operative Patient questionnaire |  | at Baseline and after surgery at day one | 
| Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire |  | at Baseline and after surgery at day one | 
| Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) |  | at Baseline and after surgery at day one | 
| Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire |  | at Baseline and after surgery at day one | 
| Change in specific quality of life measured by International Continence Society short form |  | at Baseline and at 3 months | 
| Change in specific quality of life measured by Post-Operative Patient questionnaire |  | at Baseline and at 3 months | 
| Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire |  | at Baseline and at 3 months | 
| Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) |  | at Baseline and at 3 months | 
| Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire |  | at Baseline and at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outpatient surgery, urology medico-economic, hotel