Summary of findings 2. Initiation of prophylactic therapy guided by colonoscopy compared to initiation of prophylactic therapy immediately after surgery for the prevention of postoperative recurrence of Crohn’s disease.
| Initiation of prophylactic therapy guided by colonoscopy compared to initiation of prophylactic therapy immediately after surgery for the prevention of postoperative recurrence of Crohn’s disease | ||||||
|
Patient or population: Adult participants (> 16 years of age) undergoing intestinal resection due to Crohn's disease.
Settings: Hospital outpatients Intervention: Prophylactic therapy guided by colonoscopy Comparison: Prophylactic therapy immediately after surgery | ||||||
| Outcomes |
Anticipated absolute effects* (95% CI) |
Relative effect (95% CI) |
Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
|
WITH therapy immediately after surgery |
WITH colonoscopy‐guided therapy |
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|
Clinical recurrence (until week 102) |
500 per 1000 | 580 per 1000 (365 to 920) |
RR 1.16 (0.73 to 1.84) | 63 (1 RCT) |
⊕⊝⊝⊝a,b,c VERY LOW | Clinical recurrence was defined by a CDAI >150 points |
|
Endoscopic recurrence (at week 102) |
500 per 1000 | 580 per 1000 (365 to 920) |
RR 1.16 (0.73 to 1.84) |
63 (1 RCT) |
⊕⊝⊝⊝a,b,c VERY LOW | Endoscopic recurrence was defined by a Rutgeerts' score ≥ i2 |
|
Surgical recurrence (Follow‐up: 102 weeks) |
242 per 1000 | 191 per 1000 (92 to 392) | RR 0.79 (0.38 to 1.62) |
133 (1 cohort study) |
⊕⊝⊝⊝d VERY LOW | Unadjusted risk ratio |
|
Mortality (Follow‐up: 102 weeks) |
‐ | ‐ | ‐ | 63 (1 RCT) |
‐ | No deaths were reported during the follow‐up period |
| Quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome was not measured or reported |
|
Adverse effects (Follow‐up: 102 weeks) |
938 per 1000 | 544 per 1000 (394 to 769) |
RR 0.58 (0.42 to 0.82) |
63 (1 RCT) |
⊕⊝⊝⊝a,c,e VERY LOW | Common adverse effects included infections, gastrointestinal intolerance, leukopenia, pancreatitis, skin lesions and cancer. Perforations or haemorrhages secondary to colonoscopy were not reported |
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CI 95%: 95% confidence interval (CI); RR: Risk ratio; GRADE: Evidence grades of the GRADE Working Group (see later); RCT: randomised controlled trial; CDAI: Crohn's disease activity index. *The risk WITH therapy immediately after surgery is based on the risk in the control group of the trials. The risk WITH colonoscopy‐guided therapy (and its confidence interval) is calculated from relative effect (and its confidence interval). | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
a The certainty of the evidence was downgraded in one level for risk of bias because trial was open‐label and unclear risk of attrition bias. Despite the outcome assessor was blinded for the outcome endoscopic recurrence, the participants and personnel were not blinded
b The certainty of the evidence was downgraded in one level for imprecision because the result at each end of the confidence interval entails a different clinical decision and the sample size of the included study was lower than the calculated optimal information size.
c The certainty of the evidence was downgraded in one level for indirectness, because the current practice includes management with biologic therapy and this study only considered thiopurines.
d The certainty of the evidence was downgraded in one level for imprecision because only one study was included and the result at each end of the confidence interval entails a different clinical decision.
e The certainty of the evidence was downgraded in one level for imprecision because the sample size of the included study was lower than the calculated optimal information size.