Medico-economical Evaluation of Patient-hotel in Urology

Not Applicable

Completed

• Conditions: Surgery for Prosthetic Penile Implant; Surgery for Sacral Nerve Neurostimulation; Surgery for Urinary Artificial Sphincter
• Interventions: Other: postoperative hotel; Other: conventional hospitalization

• Registration Number: NCT02890017
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Study Start: 2017-07-28
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hotel-Ambu	postoperative hotel	Outpatient surgery with a patient-hotel night
conventional hospitalization	conventional hospitalization	conventional hospitalization

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 at 3 months
Change in general quality of life postoperatively measured by SF12 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 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
Change in specific quality of life measured by International Continence Society short form	at Baseline and at 3 months

Trial Locations

Locations (1)

Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France