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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05798065
Other study ID # 2023-16151
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date June 30, 2023

Study information

Verified date January 2023
Source Radboud University Medical Center
Contact Milou van Riswijk, MD, Msc
Phone +31615280185
Email milou.vanriswijk@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3700
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Elective admission - Procedure only for insertion of nasogastric or nasojejunal (feeding) tube without any other diagnostic or therapeutic aims

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Inpatient gastrointestinal endoscopy
all inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022.

Locations

Country Name City State
Netherlands Radboud university medical center Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of inpatient endoscopy delays (IED) IED will be defined as the number of days between the planned date versus the actual date. at endoscopic procedure
Primary Difference in type of endoscopic procedure between patients with and without IED Type of endoscopic procedure: gastroscopy/colonoscopy/endoscopic retrograde cholangio-pancreaticography (ERCP) at endoscopic procedure
Primary Difference in type of sedation between patients with and without IED Type of sedation during endoscopic procedure: No sedation/conscious sedation/general anesthesia at endoscopic procedure
Secondary Median length of hospital stay length of hospital admission in days through study cohort period from 1 january 2016 until 31 december 2022
Secondary rate of 30-day readmissions percentage of readmissions within 30 days after initial discharge up to 30 days
Secondary 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 from admission till 30 days after discharge
Secondary 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 from admission till 30 days after discharge
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