Background Chronic relapsing diseases, such as ulcerative colitis, incur considerable long-term health burden to the patient and the state. Early interventions that reduce the rate of relapse could provide considerable benefits to patients and the health service. Research has shown that the appendix affects the development and activity of ulcerative colitis. Several small studies in patients with ulcerative colitis have found that appendicectomy might reduce disease relapse, hospitalisation and medication usage, with the potential to prevent the need for future major surgery. This intervention warranted further prospective and randomised investigation. Objective To assess the clinical effectiveness of laparoscopic appendicectomy in maintaining remission in adult patients with ulcerative colitis. Design An international randomised controlled trial. Setting and participants Participants were recruited from 21 hospitals across the Netherlands, Ireland and the United Kingdom. Eligible participants had established ulcerative colitis with a disease flare within the preceding 12 months but in confirmed stable remission at trial entry. Interventions Participants were randomly assigned in a 1 : 1 ratio to undergo laparoscopic appendicectomy and continued maintenance medical therapy (intervention group) or to continue maintenance medical therapy alone (control group). Main outcome measures The primary outcome was the relapse rate at 1 year, defined as a total Mayo score ≥ 5 with endoscopic subscore of 2 or 3. Secondary outcomes included time-to-first relapse, number of relapses per patient, disease activity, number of colectomies, medication use and health-related quality of life over the 12-month follow-up period. Results Between 2012 and 2022, a total of 197 eligible participants were randomised; 99 were assigned to appendicectomy and 98 to control. At baseline, the mean (± standard deviation) age was 42.7 ± 12.7 years, median disease duration 5.1 years (interquartile range 1.7–11.3). Ulcerative colitis disease extent was 39.1% proctitis, 35.5% left-sided colitis and the remainder pancolitis. The 1-year relapse rate was significantly lower in the appendicectomy group compared to control 36.4% vs. 56.1%; relative risk 0.65 (95% confidence interval 0.47 to 0.89); p = 0.005, adjusted p = 0.002). Secondary outcome measures also favoured the appendicectomy group, including a longer time-to-first relapse ( p = 0.003), a lower total Mayo score ( p = 0.02), less initiation of biologics ( p = 0.01) and higher inflammatory bowel disease-related quality of life (Inflammatory Bowel Disease Questionnaire; p = 0.006). There were two surgery-related serious adverse events (2.1%). Limitations The long trial duration, secondary to challenges in identifying eligible participants due to background changes in availability of medical therapy, then further compounded by the pandemic, may have affected external validity. The open-label design could have introduced reporting bias, specifically in relation to subjective end points. Conclusions Appendicectomy is an effective and safe intervention in the maintenance of remission in patients with ulcerative colitis, resulting in lower 1-year relapse rates compared to standard care. In addition to this, those undergoing appendicectomy experienced less disease flares overall, a prolonged time to flare, lower disease activity scores, less escalation of medication and improved quality of life. Future work Now it has been shown to be effective, more work is needed to establish how appendicectomy works, its longer-term effects beyond 1 year, and whether it may also have a beneficial role in active ulcerative colitis. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme as award number 16/61/35.
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