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NCT04411784 Clinical Trial

PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis

Inflammatory Bowel Diseases Clinical Trial

— PROTECT-ASUC  

Official title:
PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04411784
Other study ID # 284030
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2020
Est. completion date August 31, 2020

Study information
Verified date November 2022
Source Hull University Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes

Description:

The study aims to evaluate the process, evaluation and therapy variation in management of ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether there are any differences between ambulatory and hospital management in ASUC. Also to evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers
Gender All
Age group 16 Years to 100 Years
Eligibility Inclusion Criteria: - Patients aged 16 -100 inclusive - Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period Exclusion Criteria: - Patients aged 16 -100 inclusive - Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period - Admission for elective colectomy - Pouch or stoma

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust Hull

Sponsors (1)
Lead Sponsor Collaborator
Hull University Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary outcome measure: The need for in-hospital colectomy or rescue therapy The need for in-hospital colectomy or rescue therapy 3 months
Secondary 2.1: Duration and type/route of steroid use Duration and type/route of steroid use 3 months
Secondary 2.2: 30 day colectomy free survival rates 30 day colectomy free survival rates 3 months
Secondary 2.3: Covid-19 infection rates Covid-19 infection rates 3 months
Secondary 2.4: Rate of Rescue therapy use Rate of Rescue therapy use 3 months
Secondary 2.5: Duration of hospital stay Duration of hospital stay 3 months
Secondary 2.6: Admission severity scoring Admission severity scoring 3 months
Secondary 2.7: Readmission rates Readmission rates 3 months
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