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Completed

NCT Number: NCT04411784

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

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

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Key information

Conditions

Inflammatory Bowel Diseases COVID Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust

Hull, United Kingdom

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 2.1: Duration and type/route of steroid use

    Time frame: 3 months

    Duration and type/route of steroid use

  2. 2.2: 30 day colectomy free survival rates

    Time frame: 3 months

    30 day colectomy free survival rates

  3. 2.3: Covid-19 infection rates

    Time frame: 3 months

    Covid-19 infection rates

  4. 2.4: Rate of Rescue therapy use

    Time frame: 3 months

    Rate of Rescue therapy use

  5. 2.5: Duration of hospital stay

    Time frame: 3 months

    Duration of hospital stay

  6. 2.6: Admission severity scoring

    Time frame: 3 months

    Admission severity scoring

  7. 2.7: Readmission rates

    Time frame: 3 months

    Readmission rates

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: PROTECT-ASUC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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