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

NCT ID: NCT04411784

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-20

Study Completion Date

2020-08-31

Brief Summary

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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

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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

Conditions

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Inflammatory Bowel Diseases COVID

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Main group

Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period

No interventions assigned to this group

Control Group

Patients with ASUC managed in the unit from 1st Jan to 31st June 2019

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaji Sebastian

Role: PRINCIPAL_INVESTIGATOR

Hull University Teaching Hospitals

Locations

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

Hull, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35101886 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33545083 (View on PubMed)

Other Identifiers

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284030

Identifier Type: -

Identifier Source: org_study_id

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