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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411784
Recruitment Status : Active, not recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

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

Condition or disease
Inflammatory Bowel Diseases COVID

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
In The UK alone approximately 6500 patients are admitted with ASUC each year
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411784


Locations
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United Kingdom
Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Hull, United Kingdom
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
Investigators
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Principal Investigator: Shaji Sebastian Hull University Teaching Hospitals
Additional Information:
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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04411784    
Other Study ID Numbers: 284030
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases