Rapid Move Following Outpatient Surgery: Safety and Patient Characteristics (OUTSIDE)

December 18, 2024 updated by: Ella Hemie, Algemeen Ziekenhuis Maria Middelares

A Retrospective Study on the Safety of the Rapid Move Following Outpatient Surgery and the Characteristics of Patients in the Rapid Move

A descriptive, retrospective cohort study will be conducted to gain insight in the safety of the Rapid Move. The trial will include a group of Rapid Move patients, who were transferred to the Rapid Move after their outpatient surgery and subsequently discharged home. The Rapid Move is a short-stay PACU where patients recover from anaesthesia, are continuously monitored, and prepared for discharge within an hour after surgery.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

1500

Contacts and Locations

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

Study Contact

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will include an intervention group with all consecutive patients, aged 15 years or older, who went to the Rapid Move after their outpatient procedure between 1 December 2023 and 1 December 2024 in general hospital Maria Middelares, Ghent, Belgium (Rapid Move patients).

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

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

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).
A short-stay PACU where patients recover from anaesthesia, are continuously monitored, and prepared for discharge within an hour after surgery.

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
Up to 30 days after hospital discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Up to 30 days after hospital discharge.
Readmission reason, classified using the International Classification for Diseases (ICD)-11.
Up to 30 days after hospital discharge.
Length of Stay
Time Frame: Minutes, up to 4 hours.
The time between the arrival at the Rapid Move unit and the time of hospital discharge.
Minutes, up to 4 hours.

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Ella Hermie, MSc, Algemeen Ziekenhuis Maria Middelares

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 (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MMS.2024.079

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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