ACCURE-UK 2

 An international multicentre randomised controlled trial to assess the effect of Appendectomy on the Clinical Course of UlceRativE colitis; UK Arm

 ACCURE-UK_2-Logo

 

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 may have an affect the activity of UC. Several small studies in patients with active UC have found that appendicectomy reduces relapse, hospitalisation and medication usage, with the potential to impact the need for future major surgery.  

The aim of the ACCURE-UK 2 study evaluate the short- and medium-term effectiveness of appendicectomy in maintaining remission in adult patients with an established diagnosis of UC, who are currently in remission.

 

Trial Design

ACCURE-UK 2 is the UK arm of a Dutch ACCURE trial and will recruit 90 patients, to both increase the power of the main trial and help complete recruitment in a more expedient manner.

ACCURE-UK 2 is a multicentre, outcome-assessor blinded randomised controlled trial comparing laparoscopic appendicectomy plus standard medical therapy with standard medical therapy alone for patients with confirmed UC who have had a disease flare-up within the past 12 months and are currently in remission. 

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

Clinical Hypothesis

Appendicectomy will result in an improved clinical course in UC compared to those undergoing standard care, with an increased chance of maintaining remission and an associated improvement in overall symptoms.

Clinical research question

In UC patients who are in remission, compared to standard medical therapy, does laparoscopic appendicectomy lower the rate of relapse and/or prolong the time to relapse?

 

Outcomes

Primary outcome:

The one-year UC relapse rate (defined both clinically and endoscopically as Mayo-score ≥5 with endoscopy score of 2 or 3).

Secondary outcomes:

    • Number of relapses per patient at 12 months.
    • Time to first relapse.
    • Health related quality of life and costs (EQ-5D-3L, EORTC-QLQ-C30-QL and IBDQ) at 3, 6, 9 and 12 months post-randomisation.
    • Disease activity, as measured with the Mayo score at 12 months or relapse.
    • Colectomy rate at 12 months.
    • Number of semesters (6 month period) in remission since beginning of disease and current relapse.
    • Resource usage, including medication usage, diagnostic tests undergone outside of the trial (laboratory work, radiological and endoscopic assessments), inpatient costs and health professional interactions.

 

Key Eligibility Criteria

Inclusion Criteria:

    • Histologically confirmed diagnosis of ulcerative colitis
    • Disease relapse within 12 months of randomisation medically treated until remission
    • In clinical remission at time of randomisation with partial Mayo score <3 and endoscopic Mayo subscore of 0 or 1
    • Aged 18 or over
    • Able and willing to provide written informed consent

Exclusion criteria:

    • Prior appendicectomy or major abdominal surgery which precludes safe laparoscopy appendicectomy
    • Any suspicion of Crohn’s disease
    • Disease recently treated with biologicals (within 3 months of randomisation)
    • Severe disease ever treated with biologicals and stopped due to secondary non-response
    • Toxic megacolon or severe ongoing active colitis at time of randomisation
    • Medical comorbidity (e.g. COPD) that precludes safe laparoscopy

 Contact Details

For further information regarding the ACCURE-UK 2 trial contact the Trial Office on:

Email:  ACCURE@trials.bham.ac.uk

Tel:      0121 415 9104 (Manjinder Kaur - Trials Team Leader)

Tel:      0121 414 9012 (James Brown - Trial Manager)

Fax:     0121 415 8871