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

December 20, 2019 updated by: Hospices Civils de Lyon

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pierre-Bénite, France, 69310
        • Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2017

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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