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Crohn 's disease management after intestinal resection : a randomised trial . BACKGROUND Most patients with Crohn 's disease need an intestinal resection , but a majority will subsequently experience disease recurrence and require further surgery . This study aimed to identify the optimal strategy to prevent postoperative disease recurrence . METHODS In this randomised trial , consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohn 's disease , with an endoscopically accessible anastomosis , received 3 months of metronidazole therapy . Patients at high risk of recurrence also received a thiopurine , or adalimumab if they were intolerant to thiopurines . Patients were randomly assigned to parallel groups : colonoscopy at 6 months ( active care ) or no colonoscopy ( standard care ) . We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio . For endoscopic recurrence ( Rutgeerts score ≥i2 ) at 6 months , patients stepped-up to thiopurine , fortnightly adalimumab with thiopurine , or weekly adalimumab . The primary endpoint was endoscopic recurrence at 18 months . Patients and treating physicians were aware of the patient 's study group and treatment , but central reading of the endoscopic findings was undertaken blind to the study group and treatment . Analysis included all patients who received at least one dose of study drug . This trial is registered with ClinicalTrials.gov , number NCT00989560 . FINDINGS Between Oct 13 , 2009 , and Sept 28 , 2011 , 174 ( 83 % high risk across both active and standard care groups ) patients were enrolled and received at least one dose of study drug . Of 122 patients in the active care group , 47 ( 39 % ) stepped-up treatment . At 18 months , endoscopic recurrence occurred in 60 ( 49 % ) patients in the active care group and 35 ( 67 % ) patients in the standard care group ( p=0.03 ) . Complete mucosal normality was maintained in 27 ( 22 % ) of 122 patients in the active care group versus four ( 8 % ) in the standard care group ( p=0.03 ) . In the active care arm , of those with 6 months recurrence who stepped up treatment , 18 ( 38 % ) of 47 patients were in remission 12 months later ; conversely , of those in remission at 6 months who did not change therapy recurrence occurred in 31 ( 41 % ) of 75 patients 12 months later . Smoking ( odds ratio [ OR ] 2.4 , 95 % CI 1.2-4.8 , p=0.02 ) and the presence of two or more clinical risk factors including smoking ( OR 2.8 , 95 % CI 1.01-7.7 , p=0.05 ) increased the risk of endoscopic recurrence . The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups ( 100 [ 82 % ] of 122 vs 45 [ 87 % ] of 52 ; p=0.51 ) and ( 33 [ 27 % ] of 122 vs 18 [ 35 % ] of 52 ; p=0.36 ) , respectively . INTERPRETATION Treatment according to clinical risk of recurrence , with early colonoscopy and treatment step-up for recurrence , is better than conventional drug therapy alone for prevention of postoperative Crohn 's disease recurrence . Selective immune suppression , adjusted for early recurrence , rather than routine use , leads to disease control in most patients . Clinical risk factors predict recurrence , but patients at low risk also need monitoring . Early remission does not preclude the need for ongoing monitoring . FUNDING AbbVie , Gutsy Group , Gandel Philanthropy , Angior Foundation , Crohn 's Colitis Australia , and the National Health and Medical Research Council .
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Intervention_Physical
intestinal resection
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Intervention_Pharmacological
metronidazole
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Intervention_Pharmacological
thiopurine
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Intervention_Pharmacological
adalimumab
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Intervention_Surgical
colonoscopy at 6 months
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Intervention_Physical
( active care )
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Intervention_Physical
no colonoscopy ( standard care )
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Outcome_Physical
recurrence
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Outcome_Mental
endoscopic recurrence
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Outcome_Mental
The primary endpoint was endoscopic recurrence
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Outcome_Other
endoscopic recurrence
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Outcome_Other
p=0.03
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Outcome_Physical
Complete mucosal normality
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Outcome_Physical
months recurrence
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Outcome_Other
in remission
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Outcome_Mental
endoscopic recurrence
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Outcome_Adverse-effects
The incidence and type of adverse and severe adverse events
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Outcome_Mental
clinical risk of recurrence
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Outcome_Physical
postoperative Crohn 's disease recurrence
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Outcome_Physical
disease control
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Outcome_Other
predict recurrence
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Outcome_Mental
need monitoring
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Outcome_Physical
Early remission
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Participant_Condition
patients with Crohn 's disease
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Participant_Condition
Crohn 's disease
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Participant_Condition
Patients at high risk of recurrence
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Participant_Sample-size
122 patients in the active care group