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Medico-economical Evaluation of Patient-hotel in Urology (HOTELAMBU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890017
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Surgery for Sacral Nerve Neurostimulation Surgery for Urinary Artificial Sphincter Surgery for Prosthetic Penile Implant Other: postoperative hotel Other: conventional hospitalization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Medico-economical Evaluation of Patient-hotel in Urology
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: Hotel-Ambu
Outpatient surgery with a patient-hotel night
Other: postoperative hotel

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 hospitalization
conventional hospitalization
Other: conventional hospitalization
Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. postoperative complications [ Time Frame: at 3 months ]
    All postoperative complications that occur within 3 months

  2. Change in general quality of life postoperatively measured by EQ5D questionnaire [ Time Frame: at Baseline and after surgery at day one ]
  3. Change in general quality of life postoperatively measured by SF12 questionnaire [ Time Frame: at Baseline and after surgery at day one ]
  4. Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire [ Time Frame: at Baseline and at 3 moths ]
  5. Change in general quality of life at 3 months after surgery measured by SF12 questionnaire [ Time Frame: at Baseline and at 3 moths ]
  6. Change in specific quality of life measured by questionnaires International Continence Society short form [ Time Frame: at Baseline and after surgery at day one ]
  7. Change in specific quality of life measured by Post-Operative Patient questionnaire [ Time Frame: at Baseline and after surgery at day one ]
  8. 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 ]
  9. 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 ]
  10. Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire [ Time Frame: at Baseline and after surgery at day one ]
  11. Change in specific quality of life measured by International Continence Society short form [ Time Frame: at Baseline and at 3 months ]
  12. Change in specific quality of life measured by Post-Operative Patient questionnaire [ Time Frame: at Baseline and at 3 months ]
  13. Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire [ Time Frame: at Baseline and at 3 months ]
  14. Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) [ Time Frame: at Baseline and at 3 months ]
  15. Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire [ Time Frame: at Baseline and at 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890017


Locations
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France
Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02890017    
Other Study ID Numbers: 69HCl15_ 0513
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
outpatient surgery
urology medico-economic
hotel