NCT05798065

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

January 8, 2023

Last Update Submit

November 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Median length of hospital stay

    through study cohort period from 1 january 2016 until 31 december 2022

  • rate of 30-day readmissions

    up to 30 days

  • Odds ratio of presence of inpatient endoscopy delays for risk of prolonged length of hospital stay and 30-day readmissions

    from admission till 30 days after discharge

  • Odds ratio of presence of inpatient endoscopy delays for risk of 30-day readmissions

    from admission till 30 days after discharge

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Elective admission
  • Procedure only for insertion of nasogastric or nasojejunal (feeding) tube without any other diagnostic or therapeutic aims

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Study Officials

  • Peter Siersema, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Milou van Riswijk, MD, Msc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2023

First Posted

April 4, 2023

Study Start

April 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

IPD will be shared upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
15 years after publication date
Access Criteria
supporting information will be shared upon reasonable request

Locations