The ACCURE UK trial

The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE colitis - The ACCURE-UK Trial Feasibility study: a randomised clinical trial

Welcome to the ACCURE-UK trial website.

ACCURE-UK has now closed to recruitment.

 

ACCURE-UK is a 6 centre 48 patient feasibility RCT that will assess the acceptability of the appendicectomy operation and inform the design of the phase III, multi-centre randomised trial. The future phase III study will compare appendicectomy plus standard medical therapy versus standard medical therapy alone.

The Rationale for a Trial

Ulcerative Colitis (UC) is a chronic inflammatory condition of the large bowel affecting more than 50,000 people in the UK, of whom around 40% will experience a relapse annually, with up to 25% requiring total colectomy in their lifetime. Reducing relapse and progression is a priority for patients. UC patients can be treated effectively with medical therapy, either with maintenance therapy (preventing disease relapse with 5-ASA tablet medication) or breakthrough therapy (treating active disease relapses). However, even on maintenance therapy the annual disease relapse rate is around 40% which will require escalation to high dose steroid medication with its incumbent risks and toxicity.

Research has shown that the appendix affects the development and activity of UC possibly due to the appendix being a rich source of bacterial load and innate white blood cells which are important constituents of mucosal inflammation. Several small studies in patients with active UC have found that appendicectomy reduces relapse, hospitalisation and medication usage, with the potential to prevent the need for future major surgery.  

The aim of the ACCURE-UK study is to assess the feasibility and inform the design of a large, phase III, multi-centre randomised trial comparing standard medical therapy versus appendicectomy plus medical therapy

Trial Design

ACCURE-UK is a 48 patient feasibility 6 centre randomised controlled trial. The aim of the feasibility study is to assess the acceptability of the intervention and inform the design of a large phase III, multi-centre randomised control trial comparing standard medical therapy versus appendicectomy plus standard medical therapy.

The trial aims to randomise 48 patients in 6 months. 

Patients will be randomised in a 1:1 ratio between the two arms of the study and will be followed up for 12 months. 

Objectives

  • Explore whether appendicectomy is an acceptable treatment option to UC patients and clinicians and if patients are willing to be randomised to a trial where appendicectomy forms one treatment arm
  • Determine the numbers of eligible, approached and randomised patients and ascertain the optimal recruitment pathways
  • Estimate the relapse rate in the control arm to inform the sample size calculations for a future phase III trial.
  • Estimate the morbidity profile of the appendicectomy operation
  • Patient-related outcomes, e.g. patients will be asked about disease-related work absence and loss of earnings to try and establish the ability to collect social economics data.
  • Determine the suitability of the QoL outcome measures
  • Pilot bespoke health economic evaluation questionnaires
  • Test the one-year follow-up strategy for the future phase III trial. This will assess the acceptability of the follow up tools for a future phase III RCT.

 

Contact Details

For further information regarding the ACCURE-UK trial contact the trials office on:

Email:  ACCURE@trials.bham.ac.uk

Tel:      0121 415 9105 (Laura Magill - Trials Team Leader)

Tel:      0121 415 9106 (Rita Perry- Data Manager)

Fax:     0121 415 8871