Surgery for Prosthetic Penile Implant Clinical Trial
— HOTELAMBUOfficial title:
Medico-economical Evaluation of Patient-hotel in Urology
| Verified date | December 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | January 31, 2019 |
| Est. primary completion date | January 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | postoperative complications | All postoperative complications that occur within 3 months | at 3 months | |
| Secondary | Change in general quality of life postoperatively measured by EQ5D questionnaire | at Baseline and after surgery at day one | ||
| Secondary | Change in general quality of life postoperatively measured by SF12 questionnaire | at Baseline and after surgery at day one | ||
| Secondary | Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire | at Baseline and at 3 moths | ||
| Secondary | Change in general quality of life at 3 months after surgery measured by SF12 questionnaire | at Baseline and at 3 moths | ||
| Secondary | Change in specific quality of life measured by questionnaires International Continence Society short form | at Baseline and after surgery at day one | ||
| Secondary | Change in specific quality of life measured by Post-Operative Patient questionnaire | at Baseline and after surgery at day one | ||
| Secondary | Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire | at Baseline and after surgery at day one | ||
| Secondary | Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) | at Baseline and after surgery at day one | ||
| Secondary | Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire | at Baseline and after surgery at day one | ||
| Secondary | Change in specific quality of life measured by International Continence Society short form | at Baseline and at 3 months | ||
| Secondary | Change in specific quality of life measured by Post-Operative Patient questionnaire | at Baseline and at 3 months | ||
| Secondary | Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire | at Baseline and at 3 months | ||
| Secondary | Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) | at Baseline and at 3 months | ||
| Secondary | Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire | at Baseline and at 3 months |