Surgery for Sacral Nerve NeurostimulationHOTELAMBUNCT02890017
Medico-economical Evaluation of Patient-hotel in Urology
A study testing postoperative hotel and conventional hospitalization in people with Surgery for Sacral Nerve Neurostimulation and Surgery for Urinary Artificial Sphincter, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter, Surgery for Prosthetic Penile Implant
- What is being tested?
- postoperative hotel and conventional hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
About this study
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.
- Conditions
- Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter, Surgery for Prosthetic Penile Implant
- Being tested
- postoperative hotel, conventional hospitalization
- Keywords
- outpatient surgery, urology medico-economic, hotel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
conventional hospitalizationOther
Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months
| Study group | Role | What they receive |
|---|---|---|
| Hotel-Ambu | Experimental | Outpatient surgery with a patient-hotel night Receives: Other: postoperative hotel |
| conventional hospitalization | Other | conventional hospitalization Receives: Other: conventional hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 months
Secondary outcomes (15)
postoperative complications
All postoperative complications that occur within 3 months
Measured: at 3 months
Change in general quality of life postoperatively measured by EQ5D questionnaire
Measured: at Baseline and after surgery at day one
Change in general quality of life postoperatively measured by SF12 questionnaire
Measured: at Baseline and after surgery at day one
Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire
Measured: at Baseline and at 3 moths
Change in general quality of life at 3 months after surgery measured by SF12 questionnaire
Measured: at Baseline and at 3 moths
Change in specific quality of life measured by questionnaires International Continence Society short form
Measured: at Baseline and after surgery at day one
Change in specific quality of life measured by Post-Operative Patient questionnaire
Measured: at Baseline and after surgery at day one
Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire
Measured: at Baseline and after surgery at day one
Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
Measured: at Baseline and after surgery at day one
Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
Measured: at Baseline and after surgery at day one
Change in specific quality of life measured by International Continence Society short form
Measured: at Baseline and at 3 months
Change in specific quality of life measured by Post-Operative Patient questionnaire
Measured: at Baseline and at 3 months
Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire
Measured: at Baseline and at 3 months
Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)
Measured: at Baseline and at 3 months
Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire
Measured: at Baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start28 Jul 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery for Sacral Nerve NeurostimulationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890017
- Sponsor's protocol ID
- 69HCl15_ 0513
- Acronym
- HOTELAMBU
- Status last verified
- Dec 2019
- First submitted
- 24 Aug 2016
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economical Evaluation of Patient-hotel in Urology
- ClinicalTrials.gov ID
- NCT02890017
- Acronym / sponsor ID
- HOTELAMBU / 69HCl15_ 0513
- Conditions
- Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter, Surgery for Prosthetic Penile Implant
- Keywords
- outpatient surgery, urology medico-economic, hotel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hotel-Ambu | Experimental | Other: postoperative hotelOutpatient surgery with a patient-hotel night |
| conventional hospitalization | Other | Other: conventional hospitalizationconventional hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative hotelOutpatient 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 | Hotel-Ambu |
| conventional hospitalizationHospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months | Other | conventional hospitalization |
Primary outcome
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.
15 secondary outcomes
postoperative complications
Time frame: at 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative hotel and conventional hospitalization in people with Surgery for Sacral Nerve Neurostimulation and Surgery for Urinary Artificial Sphincter, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY) (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.