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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04411784

Acronym

PROTECT-ASUC

Enrollment

Registered

2020-06-02

Start date

2020-05-20

Completion date

2020-08-31

Last updated

2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, Inflammatory Bowel Diseases

Brief 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

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 100 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results