Medico-economical Evaluation of Patient-hotel in Urology

Hospices Civils de Lyon10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

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

Interventions

postoperative hotelOTHER

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.

conventional hospitalizationOTHER

Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, France

Outcomes

Primary Outcomes

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.

Time frame: at 3 months

Secondary Outcomes

postoperative complications

All postoperative complications that occur within 3 months

Time frame: at 3 months

Change in general quality of life postoperatively measured by EQ5D questionnaire

Time frame: at Baseline and after surgery at day one

Change in general quality of life postoperatively measured by SF12 questionnaire

Time frame: at Baseline and after surgery at day one

Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire

Time frame: at Baseline and at 3 moths

Change in general quality of life at 3 months after surgery measured by SF12 questionnaire

Time frame: at Baseline and at 3 moths

Change in specific quality of life measured by questionnaires International Continence Society short form

Time frame: at Baseline and after surgery at day one

Data from ClinicalTrials.gov

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