HOTELAMBU: Medico-economical Evaluation of Patient-hotel in Urology

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02890017
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jul 28, 2017
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. postoperative complications [at 3 months]

   All postoperative complications that occur within 3 months

2. Change in general quality of life postoperatively measured by EQ5D questionnaire [at Baseline and after surgery at day one]

3. Change in general quality of life postoperatively measured by SF12 questionnaire [at Baseline and after surgery at day one]

4. Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire [at Baseline and at 3 moths]

5. Change in general quality of life at 3 months after surgery measured by SF12 questionnaire [at Baseline and at 3 moths]

6. Change in specific quality of life measured by questionnaires International Continence Society short form [at Baseline and after surgery at day one]

7. Change in specific quality of life measured by Post-Operative Patient questionnaire [at Baseline and after surgery at day one]

8. Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire [at Baseline and after surgery at day one]

9. Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) [at Baseline and after surgery at day one]

10. Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire [at Baseline and after surgery at day one]

11. Change in specific quality of life measured by International Continence Society short form [at Baseline and at 3 months]

12. Change in specific quality of life measured by Post-Operative Patient questionnaire [at Baseline and at 3 months]

13. Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire [at Baseline and at 3 months]

14. Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF) [at Baseline and at 3 months]

15. Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire [at Baseline and at 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite		France	69310

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02890017
• Other Study ID Numbers: 69HCl15_ 0513
• First Posted: Sep 7, 2016
• Last Update Posted: Dec 23, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Dec 23, 2019