Surgery for Prosthetic Penile Implant, Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter
Conditions
Keywords
outpatient surgery, urology medico-economic, hotel
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.
Interventions
OTHERpostoperative hotel
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.
Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY) | at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | at 3 months | All postoperative complications that occur within 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 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 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 questionnaires International Continence Society short form | at Baseline and after surgery at day one | — |
Countries
France
Outcome results
None listed