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 / |
| Profile Link |
Lead Centre
|
Queen Mary Pragmatic Trials Unit Blizard Institute, 58 Turner Street London E1 2AB UK |
| Website |
Collaboration and Funding
Funding Sponsors
| 1. Not yet funded |
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 |