- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06742658
Rapid Move Following Outpatient Surgery: Safety and Patient Characteristics (OUTSIDE)
A Retrospective Study on the Safety of the Rapid Move Following Outpatient Surgery and the Characteristics of Patients in the Rapid Move
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Rapid Move, a short-stay PACU unit, was implemented at General Hospital Maria Middelares in Ghent, Belgium. The Rapid Move is designed to alleviate the bottleneck in the day surgery unit. Overcrowding in the PACU, caused by limited space in the day surgery unit, resulted in delays in patient discharge despite patients meeting discharge criteria. The Rapid Move is designed for brief, intensive follow-up care, similar to the PACU, with continuous monitoring and a nurse-to-patient ratio of 2:9. An analysis of the occupancy rate of the PACU and the Rapid Move indicates that, despite overcrowding in the PACU, the Rapid Move is still underutilised. Despite the extensive research on PACU bypassing, to our knowledge, no research has been conducted on the safety of the Rapid Move, a short-stay PACU where patients recover from anaesthesia, are continuously monitored and prepared for discharge within an hour after surgery. The aim of this retrospective cohort study is to gain insight in the safety of the Rapid Move as an alternative postoperative pathway for outpatients.
Furthermore, the underutilisation of the Rapid Move, despite the overcrowding of the PACU, has highlighted the need to develop a patient profile of eligible patients for the Rapid Move, with the intention to expand the selection criteria for the Rapid Move and optimise its capacity.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ella Hermie, MSc
- Phone Number: 0032 9 246 17 03
- Email: ella.hermie@mijnziekenhuis.be
Study Locations
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Ghent, Belgium, 9000
- AZ Maria Middelares
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Contact:
- Ella Hermie
- Email: ella.hermie@mijnziekenhuis.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 15 years or older;
- Patients who went to the Rapid Move after their outpatient procedure. Eligible procedures are: gastroscopy, coloscopy, vasectomy, scrotal surgery, circumcision or other minor penile surgery, intravesical Botox, insertion or removal of eardrum tubes in adults, sinus irrigation in adults, sleep endoscopy, bronchoscopy, removal of osteosynthetic material in the lower leg and foot, and tooth extraction (including wisdom teeth) and upper-forearm orthopedic surgery (excluding prosthetic surgery).
Exclusion Criteria:
- Inpatients defined as a patient who is formally admitted (or "hospitalized") to an institution for treatment and/or care and stays for a minimum of one night in the hospital or other institution providing inpatient care;
- Patients undergoing emergency procedures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
All patients undergoing an outpatient procedure eligible for the Rapid Move.
Patients who went to the Rapid Move after their outpatient procedure.
Eligible procedures are: gastroscopy, coloscopy, vasectomy, scrotal surgery, circumcision or other minor penile surgery, intravesical Botox, insertion or removal of eardrum tubes in adults, sinus irrigation in adults, sleep endoscopy, bronchoscopy, removal of osteosynthetic material in the lower leg and foot, and tooth extraction (including wisdom teeth) and upper-forearm orthopaedic surgery (excluding prosthetic surgery).
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A short-stay PACU where patients recover from anaesthesia, are continuously monitored, and prepared for discharge within an hour after surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day readmission
Time Frame: Up to 30 days after hospital discharge.
|
The 30-day readmission rate is defined as the number of patients with an unplanned emergency hospital readmission, including emergency department (ED) visits with or without hospital readmission, occurring between the time the patient is discharged from the hospital after their outpatient surgery (index hospital admission) and 30 days after the surgery.
An admission to a non-acute care facility is not considered a readmission.
A readmission must be clinically related to the index hospital admission.
The term 'clinically related' is defined as meaning that the underlying reason for readmission is plausibly related to the care rendered during or immediately following a prior hospital admission.
A clinically related readmission may have resulted from the process of care and treatment during the prior admission or from a lack of post-admission follow-up, rather than from events that occurred after the prior admission within a specified readmission time interval that are unrelated to the p
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Up to 30 days after hospital discharge.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Complications
Time Frame: Up to 30 days after hospital discharge.
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Readmission reason, classified using the International Classification for Diseases (ICD)-11.
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Up to 30 days after hospital discharge.
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Length of Stay
Time Frame: Minutes, up to 4 hours.
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The time between the arrival at the Rapid Move unit and the time of hospital discharge.
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Minutes, up to 4 hours.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ella Hermie, MSc, Algemeen Ziekenhuis Maria Middelares
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MMS.2024.079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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