NCT02890017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

July 28, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

August 24, 2016

Last Update Submit

December 20, 2019

Conditions

Surgery for Sacral Nerve NeurostimulationSurgery for Urinary Artificial SphincterSurgery for Prosthetic Penile Implant

Keywords

outpatient surgeryurology medico-economichotel

Outcome Measures

Primary Outcomes (1)

  • ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY)

    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 Outcomes (15)

  • postoperative complications

    at 3 months

  • Change in general quality of life postoperatively measured by EQ5D questionnaire

    at Baseline and after surgery at day one

  • Change in general quality of life postoperatively measured by SF12 questionnaire

    at Baseline and after surgery at day one

  • Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire

    at Baseline and at 3 moths

  • Change in general quality of life at 3 months after surgery measured by SF12 questionnaire

    at Baseline and at 3 moths

  • +10 more secondary outcomes

Study Arms (2)

Hotel-Ambu

EXPERIMENTAL

Outpatient surgery with a patient-hotel night

Other: postoperative hotel

conventional hospitalization

OTHER

conventional hospitalization

Other: conventional hospitalization

Interventions

postoperative hotelOTHER

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.

Hotel-Ambu
conventional hospitalizationOTHER

Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months

conventional hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 7, 2016

Study Start

July 28, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)