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

November 3, 2022 updated by: Hull University Teaching Hospitals NHS Trust

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

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

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

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

Study Locations

  • United Kingdom
      • Hull, United Kingdom
        • Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust

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

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In The UK alone approximately 6500 patients are admitted with ASUC each year

Description

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 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
Main group
Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period
Control Group
Patients with ASUC managed in the unit from 1st Jan to 31st June 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome measure: The need for in-hospital colectomy or rescue therapy
Time Frame: 3 months
The need for in-hospital colectomy or rescue therapy
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2.1: Duration and type/route of steroid use
Time Frame: 3 months
Duration and type/route of steroid use
3 months
2.2: 30 day colectomy free survival rates
Time Frame: 3 months
30 day colectomy free survival rates
3 months
2.3: Covid-19 infection rates
Time Frame: 3 months
Covid-19 infection rates
3 months
2.4: Rate of Rescue therapy use
Time Frame: 3 months
Rate of Rescue therapy use
3 months
2.5: Duration of hospital stay
Time Frame: 3 months
Duration of hospital stay
3 months
2.6: Admission severity scoring
Time Frame: 3 months
Admission severity scoring
3 months
2.7: Readmission rates
Time Frame: 3 months
Readmission rates
3 months

Collaborators and Investigators

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

Sponsor

Hull University Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Shaji Sebastian, Hull University Teaching Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

May 20, 2020

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 284030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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