- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890017
Medico-economical Evaluation of Patient-hotel in Urology (HOTELAMBU)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pierre-Bénite, France, 69310
- Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hotel-Ambu
Outpatient surgery with a patient-hotel night
|
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. |
Other: conventional hospitalization
|
Hospitalization for surgery and first postoperative night stay.
Postoperative consultation at 1 and 3 months
|
What is the study measuring?
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)
Time Frame: at 3 months
|
Efficacity (QALY) is a composite measure of quality of life and adverse events occurence:
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
Time Frame: at 3 months
|
All postoperative complications that occur within 3 months
|
at 3 months
|
Change in general quality of life postoperatively measured by EQ5D questionnaire
Time Frame: at Baseline and after surgery at day one
|
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
|
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
|
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
|
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
|
at Baseline and after surgery at day one
|
|
Change in specific quality of life measured by Post-Operative Patient questionnaire
Time Frame: at Baseline and after surgery at day one
|
at Baseline and after surgery at day one
|
|
Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire
Time Frame: at Baseline and after surgery at day one
|
at Baseline and after surgery at day one
|
|
Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
Time Frame: at Baseline and after surgery at day one
|
at Baseline and after surgery at day one
|
|
Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
Time Frame: at Baseline and after surgery at day one
|
at Baseline and after surgery at day one
|
|
Change in specific quality of life measured by International Continence Society short form
Time Frame: at Baseline and at 3 months
|
at Baseline and at 3 months
|
|
Change in specific quality of life measured by Post-Operative Patient questionnaire
Time Frame: at Baseline and at 3 months
|
at Baseline and at 3 months
|
|
Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire
Time Frame: at Baseline and at 3 months
|
at Baseline and at 3 months
|
|
Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
Time Frame: at Baseline and at 3 months
|
at Baseline and at 3 months
|
|
Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
Time Frame: at Baseline and at 3 months
|
at Baseline and at 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCl15_ 0513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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