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

NCT04411784 | Completed

• 1 other identifier: 284030
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases; COVID

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure: The need for in-hospital colectomy or rescue therapy

  The need for in-hospital colectomy or rescue therapy

  3 months

Secondary Outcomes (7)

• 2.1: Duration and type/route of steroid use

  3 months

• 2.2: 30 day colectomy free survival rates

  3 months

• 2.3: Covid-19 infection rates

  3 months

• 2.4: Rate of Rescue therapy use

  3 months

• 2.5: Duration of hospital stay

  3 months

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients aged 16 -100 inclusive
• Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

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

Hull, United Kingdom

Location

Related Publications (2)

• Sebastian S, Patel KV, Segal JP, Subramanian S, Conley TE, Gonzalez HA, Kent AJ, Saifuddin A, Hicks L, Mehta S, Bhala N, Brookes MJ, Lamb CA, Kennedy NA; PROTECT ASUC collaborators; Walker GJ. Ambulatory care management of 69 patients with acute severe ulcerative colitis in comparison to 695 inpatients: insights from a multicentre UK cohort study. BMJ Open Gastroenterol. 2022 Jan;9(1):e000763. doi: 10.1136/bmjgast-2021-000763.

  PMID: 35101886 DERIVED

• Sebastian S, Walker GJ, Kennedy NA, Conley TE, Patel KV, Subramanian S, Kent AJ, Segal JP, Brookes MJ, Bhala N, Gonzalez HA, Hicks LC, Mehta SJ, Lamb CA; PROTECT-ASUC Study Group. Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study. Lancet Gastroenterol Hepatol. 2021 Apr;6(4):271-281. doi: 10.1016/S2468-1253(21)00016-9. Epub 2021 Feb 2.

  PMID: 33545083 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Shaji Sebastian

  Hull University Teaching Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: May 20, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

GB (1)