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

Completed

• Conditions: COVID; Inflammatory Bowel Diseases

• Registration Number: NCT04411784
• Lead Sponsor: 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

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 Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure: The need for in-hospital colectomy or rescue therapy	3 months	The need for in-hospital colectomy or rescue therapy

Secondary Outcome Measures

Name	Time	Method
2.1: Duration and type/route of steroid use	3 months	Duration and type/route of steroid use
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
2.5: Duration of hospital stay	3 months	Duration of hospital stay
2.6: Admission severity scoring	3 months	Admission severity scoring
2.7: Readmission rates	3 months	Readmission rates

Trial Locations

Locations (1)

Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust; 🇬🇧 Hull, United Kingdom