SynthesisColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland2026
A systematic review of the methodological quality of randomised trials in IBD surgery.
Synthesis in Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThis systematic review aimed to evaluate the design, statistical robustness and real-world applicability of randomised controlled trials in IBD surgery.
methodsA 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).
resultsFrom 5803 abstracts, 18 published RCTs and 26 registered but unpublished trials were identified.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 Of registered, unpublished trials, median planned sample size was 155 (IQR 93-196), with the largest study having a planned enrolment of 550 participants.
conclusionsSurgical 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.
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