Inpatient Endoscopy DelayImpatienceNCT05798065
Inpatient Endoscopy Procedure Planning Delays and Impact on Length of Stay and 30-day Readmission
An observational study of Inpatient Endoscopy Delay and Readmission, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Single center retrospective cohort study of all inpatient endoscopy procedures to asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inpatient Endoscopy Delay, Readmission, Prolonged Hospital Stay
- What is being tested?
- Inpatient gastrointestinal endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 3,700 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult inpatients from all hospital departments undergoing endoscopy procedures. Patients will be selected via CTCue, with an admission based query that selects all adult patients with an admission of at least two days between 1-1-2014 and 1-12-2022 AND an endoscopic care activity.
Who may be able to join
- Adult patients (>18 years)
- Clinical admission in any hospital department of at least two days during 1 January 2016 and 1 December 2022
- Endoscopic procedure during clinical admission, including gastroscopy, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), flexible sigmoidoscopy, colonoscopy
Who cannot join
- Elective admission
- Procedure only for insertion of nasogastric or nasojejunal (feeding) tube without any other diagnostic or therapeutic aims
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Single center retrospective cohort study of all inpatient endoscopy procedures to asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission
Read the detailed description
Background: Delays in inpatient endoscopy planning negatively influence the quality and accessibility of care. This may result in higher healthcare costs, negative health outcomes, and unnecessary readmissions and use of hospital beds. Additionally, prolonged hospital stay is associated with poorer health outcomes and risk of nosocomial infections, amongst others.
Objective: To asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission
Study design: Single center retrospective cohort study of all inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022. Data will be identified and extracted using CTCue. Only pseudonymized data will be used. Inpatient endoscopy delay will be defined as the number of days between the planned date versus the actual date. Multivariable logistic regression models will be performed to assess factors associated with inpatient endoscopy delay.
- Being tested
- Inpatient gastrointestinal endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient gastrointestinal endoscopyProcedure or surgery
all inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of inpatient endoscopy delays (IED)
IED will be defined as the number of days between the planned date versus the actual date.
Measured: at endoscopic procedure
Difference in type of endoscopic procedure between patients with and without IED
Type of endoscopic procedure: gastroscopy/colonoscopy/endoscopic retrograde cholangio-pancreaticography (ERCP)
Measured: at endoscopic procedure
Difference in type of sedation between patients with and without IED
Type of sedation during endoscopic procedure: No sedation/conscious sedation/general anesthesia
Measured: at endoscopic procedure
Secondary outcomes (4)
Median length of hospital stay
length of hospital admission in days
Measured: through study cohort period from 1 january 2016 until 31 december 2022
rate of 30-day readmissions
percentage of readmissions within 30 days after initial discharge
Measured: up to 30 days
Odds ratio of presence of inpatient endoscopy delays for risk of prolonged length of hospital stay and 30-day readmissions
multivariable logistic regression modelling to assess factors associated with both outcomes and the impact of inpatient endoscopy delay
Measured: from admission till 30 days after discharge
Odds ratio of presence of inpatient endoscopy delays for risk of 30-day readmissions
multivariable logistic regression modelling to assess factors associated with both outcomes and the impact of inpatient endoscopy delay
Measured: from admission till 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inpatient Endoscopy DelayStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Siersema, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798065
- Sponsor's protocol ID
- 2023-16151
- Other IDs
- 2023
- Acronym
- Impatience
- Status last verified
- Nov 2024
- First submitted
- 8 Jan 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Endoscopy Procedure Planning Delays and Impact on Length of Stay and 30-day Readmission
- ClinicalTrials.gov ID
- NCT05798065
- Acronym / sponsor ID
- Impatience / 2023-16151
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,700 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Apr 2023 (actual)
- 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.
Single center retrospective cohort study of all inpatient endoscopy procedures to asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission
Detailed description
Background: Delays in inpatient endoscopy planning negatively influence the quality and accessibility of care. This may result in higher healthcare costs, negative health outcomes, and unnecessary readmissions and use of hospital beds. Additionally, prolonged hospital stay is associated with poorer health outcomes and risk of nosocomial infections, amongst others.
Objective: To asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission
Study design: Single center retrospective cohort study of all inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022. Data will be identified and extracted using CTCue. Only pseudonymized data will be used. Inpatient endoscopy delay will be defined as the number of days between the planned date versus the actual date. Multivariable logistic regression models will be performed to assess factors associated with inpatient endoscopy delay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients from all hospital departments undergoing endoscopy procedures. Patients will be selected via CTCue, with an admission based query that selects all adult patients with an admission of at least two days between 1-1-2014 and 1-12-2022 AND an endoscopic care activity.
Key inclusion criteria (3 listed)
- Adult patients (>18 years)
- Clinical admission in any hospital department of at least two days during 1 January 2016 and 1 December 2022
- Endoscopic procedure during clinical admission, including gastroscopy, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), flexible sigmoidoscopy, colonoscopy
Key exclusion criteria (2 listed)
- Elective admission
- Procedure only for insertion of nasogastric or nasojejunal (feeding) tube without any other diagnostic or therapeutic aims
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 |
|---|---|---|
| Inpatient gastrointestinal endoscopyall inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022. | Procedure or surgery | – |
Primary outcome
Rate of inpatient endoscopy delays (IED)
Time frame: at endoscopic procedure
IED will be defined as the number of days between the planned date versus the actual date.
Difference in type of endoscopic procedure between patients with and without IED
Time frame: at endoscopic procedure
Type of endoscopic procedure: gastroscopy/colonoscopy/endoscopic retrograde cholangio-pancreaticography (ERCP)
Difference in type of sedation between patients with and without IED
Time frame: at endoscopic procedure
Type of sedation during endoscopic procedure: No sedation/conscious sedation/general anesthesia
4 secondary outcomes
Median length of hospital stay
Time frame: through study cohort period from 1 january 2016 until 31 december 2022
rate of 30-day readmissions
Time frame: up to 30 days
Odds ratio of presence of inpatient endoscopy delays for risk of prolonged length of hospital stay and 30-day readmissions
Time frame: from admission till 30 days after discharge
Odds ratio of presence of inpatient endoscopy delays for risk of 30-day readmissions
Time frame: from admission till 30 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request
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.
Peter Siersema, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inpatient Endoscopy Delay and Readmission, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Nov 2024. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milou van Riswijk, MD, Msc (+31615280185, milou.vanriswijk@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of inpatient endoscopy delays (IED) (time frame: at endoscopic procedure). The study lists 3 primary outcomes in all. 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 21 Nov 2024.