Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310, France
Completed
NCT Number: NCT02890017
Medico-economical Evaluation of Patient-hotel in Urology
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
postoperative hotel
OtherOutpatient 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 hospitalization
OtherHospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months
Primary outcomes
-
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:
- 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 outcomes
-
postoperative complications
Time frame: at 3 months
All postoperative complications that occur within 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
-
Change in specific quality of life measured by Post-Operative Patient questionnaire
Time frame: 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
-
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
-
Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
Time frame: 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
-
Change in specific quality of life measured by Post-Operative Patient questionnaire
Time frame: 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
-
Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
Time frame: 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
Sponsors and collaborators
Lead sponsor
Hospices Civils de Lyon
Other
Registry information
Acronym: HOTELAMBU
Important dates
- Study start
- 2017
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Sep 7, 2016
- Registry last updated
- Dec 23, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.