Risk stratification |
Stratification on clinical and histological risk factors
Not prospectively validated
Uncertainty about the risk threshold for instituting prophylaxis
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Prospective risk factor validation
Development of refined clinical prediction models
Risk-benefit analysis of upfront prophylaxis vs. step-up treatment in prospective cohorts
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Diagnosing recurrence |
Ileocolonoscopy at 6–12 months as the gold standard
Endoscopic assessment using the Rutgeerts score
Uncertainty about the prognostic implications of anastomotic lesions
Uncertainty about the performance of emerging endoscopic indices (POCER, REMIND)
Emerging role of noninvasive diagnostic modalities for diagnosing recurrence (stool- and serum-based biomarkers, MRE, intestinal ultrasound)
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Defining the prognosis of lesions in the neoterminal ileum vs. lesions confined to the anastomosis in large prospective cohorts
Comparison of the impact of different endoscopic indices on treatment outcomes
Comparison of performance of endoscopic indices with different configurations of surgical anastomoses
Full validation of POCER and REMIND indices
Development of noninvasive monitoring algorithms with less reliance on endoscopy
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Treatment |
No drug has regulatory approval for the prevention of postoperative recurrence of Crohn’s disease
No dedicated regulatory guidance for clinical trial design for this indication
Infliximab is best supported by evidence, but was superior to placebo for the endoscopic, not clinical endpoint
Drugs with tenuous evidence base (metronidazole, thiopurines, aminosalicylates) remain widely used
No controlled studies of biologics other than TNF antagonists
Little data to guide treatment decisions after TNF antagonist failure
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Development of regulatory guidance incorporating and endoscopic primary endpoint
Performance of controlled trials for biologics other than TNF antagonists with particular emphasis on patients after TNF antagonist failure
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