Diverticular Abscess Management a Single Blinded Cohort Study

Trial Overview

Acronym	DAMASCUS
Number	n/a
Protocol Link	n/a
Public Trial Registry Link	n/a
Status	In Preparation/Starting
Category	Diverticular Disease
Treatment Course	Surgery

Trial Description

A prospective "enhanced" cohort study to look at the natural history of patients presenting with diverticular abscesses. The study will incorporate a nested case control study to assess the effects of surgical resection (at any time point throughout study) using patient reported quality of life as the primary outcome. The study is being run as a 2020 vision study across the Tripartite nations with a planned launch date in 2020 at the Tripartite meeting.

Chief Investigator

Mr Dale Vimalachandran/Professor Charles Knowles
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Profile Link

Lead Centre

Queen Mary Pragmatic Trials Unit
Blizard Institute, 58 Turner Street
London
E1 2AB
UK

Website

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	To prospectively observe the management of patients with diverticular abscesses.
Aim:	1. Prospectively observe the natural history of patients presenting with diverticular abscesses according to initial management at index admission 2. To determine the effectiveness or not of surgical resection (vs. non-surgical management) in patients with diverticular abscesses based on a superiority margin of 0.1 using EQ-5D-5L and 1.0 using MYMOP scores in those patients whom fail initial conservative treatment. 4.3 Secondary Objectives 3. Record national and international variation in initial management (at index admission). 4. Admission (main disease- and patient-specific) covariates that affect initial treatment decisions and may predict failure of surgical/non-surgical management 5. If timing of surgery is important in terms of effectiveness (indicatively whether early is better than late surgery) based on EQ-5D-5L and MYMOP analysis 6. If timing of surgery is important in terms of a basic measure of health utilisation (defined by readmission rates) 7. Correlate patient reported symptoms (MYMOP scores) and quality of life (EQ-5D-5L) in patients with diverticular abscesses 8. Feasibility of creating a long-term observational cohort of patients for further studies of disease biology, genetic risk, including randomised trials of different interventions to manage diverticulitis (trial within a cohort study).
Methods:	Prospective, observational only , multicentre study with nested case control study
Reason for International Trial:	1. To observe international variation in management at index admission 2. To obtain satisfactory numbers approx. 1000 Please note we plan to open approx. 50 sites across the Tripartite nations for this study. Planned funder is NIHR HTA programme with small programme grants in rets of Tripartite nations