A systematic review of the methodological quality of randomised trials in
IBD
surgery
Kelsey Aimar, Aditya Gaur, Michael Peirson, Josephine Walshaw, Thomas D. Pinkney, Matthew J. Lee Abstract
Aims
This systematic review aimed to evaluate the design, statistical robustness and real‐world applicability of randomised controlled trials in IBD surgery.
Methods
A systematic review of RCTs involving adult patients with IBD undergoing surgical interventions was conducted. Databases and registries were searched from 2005 to 2025. Dual screening and extraction were performed. Trials were appraised using RoB‐2, PRECIS‐2 and fragility index. The study was registered with PROSPERO (CRD420251058758).
Results
From 5803 abstracts, 18 published RCTs and 26 registered but unpublished trials were identified. Published RCTs had a median planned sample size of 102 participants (IQR 80–143) and recruited a median of 89 (IQR 55–114), with frequent under‐recruitment (7/18, 39%) and early termination (5/18, 28%). Methodological appraisal revealed that most studies (12/18, 67%) had some concern for bias on RoB‐2 assessment. PRECIS‐2 evaluation showed a tendency towards pragmatic designs. The median fragility index was 3 (IQR 1–6). Of registered, unpublished trials, median planned sample size was 155 (IQR 93–196), with the largest study having a planned enrolment of 550 participants.
Conclusions
Surgical RCTs in IBD face challenges across design and delivery, such as modest sample sizes, under‐recruitment and statistical fragility. The findings from this review highlight the importance of larger, multicentre and collaborative trials to strengthen the evidence base in IBD surgery.