SP 11.12 A Systematic Review of the Methodological Quality of Randomised Trials in IBD Surgery
Kelsey Aimar, Aditya Gaur, Michael Peirson, Josephine Walshaw, Thomas Pinkney, Matthew LeeAbstract
Aims
To examine contemporary surgical randomised controlled trials (RCTs) in inflammatory bowel disease (IBD) and appraise methodological quality, statistical robustness, and real-world applicability.
Methods
A systematic review of RCTs including adults with IBD undergoing surgical interventions was undertaken. Electronic databases (CENTRAL, Embase, MEDLINE) and clinical trial registries were searched (2005–2025). Dual screening, data extraction, and risk of bias assessment were performed. Trials were evaluated using PRECIS-2 and the Fragility/Reverse Fragility Index. Registered but unpublished trials were also analysed. The review was prospectively registered (CRD420251058758).
Results
From 5,803 identified records, 18 published RCTs and 26 registered but unpublished trials were included. Median planned sample size of published RCTs was 102 (IQR 80–143), with a median of 89 (IQR 55–114) recruited. Under-recruitment occurred in 39% (7/18) and early termination in 28% (5/18). Most studies (67%) raised some concerns about bias on RoB-2, and PRECIS-2 demonstrated predominantly pragmatic designs. Ten trials were eligible for fragility analysis; the median Fragility Index for statistically significant outcomes was 3 (IQR 1–6), and the Reverse Fragility Index was 4 (IQR 3–8). Registered, unpublished trials had a higher median intended sample size (155; IQR 93–196), with Crohn’s disease studies predominating (22/26).
Conclusions
Surgical RCTs in IBD are predominantly pragmatic but frequently limited by modest sample size, under-recruitment, early termination, and statistical fragility. Future trials should be larger, multicentre and collaboratively delivered to enhance power, external validity, and the evidence base for surgical management in IBD.