Clinical trial NCT04411784: PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
COVID
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In The UK alone approximately 6500 patients are admitted with ASUC each year

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

Eligibility 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

Primary outcomes:
measure: Primary outcome measure: The need for in-hospital colectomy or rescue therapy
timeFrame: 3 months
Secondary outcomes:
measure: 2.1: Duration and type/route of steroid use
timeFrame: 3 months
measure: 2.2: 30 day colectomy free survival rates
timeFrame: 3 months
measure: 2.3: Covid-19 infection rates
timeFrame: 3 months
measure: 2.4: Rate of Rescue therapy use
timeFrame: 3 months
measure: 2.5: Duration of hospital stay
timeFrame: 3 months
measure: 2.6: Admission severity scoring
timeFrame: 3 months
measure: 2.7: Readmission rates
timeFrame: 3 months
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Study officials:
affiliation: Hull University Teaching Hospitals
name: Shaji Sebastian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.