AI Article Synopsis
- - The ACCURE trial investigates whether adding laparoscopic appendectomy to standard medical treatment is effective in preventing relapses in patients with ulcerative colitis (UC) when compared to treatment alone.
- - Patients included in the trial were either newly diagnosed or had experienced a relapse in the past year, and were randomly assigned to receive either the appendectomy combined with maintenance therapy or just the maintenance therapy.
- - The main goal is to assess the one-year rate of UC relapses, along with secondary outcomes like the frequency of relapses, time until first relapse, and overall quality of life for the patients.
Article Abstract
Background: The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients. This article presents the statistical analysis plan to evaluate the outcomes of the ACCURE trial.
Design And Methods: The ACCURE trial was designed as a multicentre, randomised controlled trial. UC patients with a new diagnosis or a disease relapse within the past 12 months, treated with 5-ASA, corticosteroids, or immunomodulators until complete clinical and endoscopic remission (defined as total Mayo score < 3 with endoscopic subscore of 0 or 1), were counselled for inclusion. Also, patients previously treated with biologicals who had a washout period of at least 3 months were considered for inclusion. Patients were randomised (1:1) to laparoscopic appendectomy plus maintenance treatment or a control group (maintenance therapy only). The primary outcome is the 1-year UC relapse rate (defined as a total Mayo-score ≥ 5 with endoscopic subscore of 2 or 3, or clinically as an exacerbation of symptoms and rectal bleeding or FCP > 150 or intensified medical therapy other than 5-ASA therapy). Secondary outcomes include number of relapses per patient, time to first relapse, disease activity, number of colectomies, medication usage, and health-related quality of life.
Discussion: The ACCURE trial will provide comprehensive evidence whether adding an appendectomy to maintenance treatment is superior to maintenance treatment only in maintaining remission in UC patients.
Trial Registration: Dutch Trial Register (NTR) NTR2883 . Registered May 3, 2011. ISRCTN, ISRCTN60945764 . Registered August 12, 2019.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10964679 | PMC |
| http://dx.doi.org/10.1186/s13063-024-08037-5 | DOI Listing |
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