Ferrante 2017.
Study characteristics | ||
Methods | Retrospective cohort. Enrolment period: 2006 to 2016 | |
Participants | Country: Belgium. UC patients who underwent colectomy. Patients who were treated with investigational products and who were anticipated to have a permant ileostomy were excluded | |
Interventions | 1. Preoperative mesalamine (n= 97) 2. Preoperative thiopurine/methotrexate (n= 38) 3. Preoperative steroids (n= 32) 4. Preoperative anti‐TNF medications within 8 weeks of surgery (n= 60) 5. Preoperative vedolizumab within 16 weeks of surgery (n= 34) 6. No preoperative mesalamine (n= 73) 7. No preoperative thiopurine/methotrexate (n= 132) 8. No preoperative steroids (n= 138) 9. No preoperative anti‐TNF medications (n= 110) 10. No preoperative vedolizumab (n= 136) |
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Outcomes | Pouch specific infectious complications, surgical site infections, non‐surgical site infections within 30 days of surgery | |
Notes | NOS very high risk of bias overall Unadjusted ORs for preoperative mesalamine, thiopurine/methotrexate, steroids, anti‐TNF therapy, and vedolizumab were obtained from univariate regre ssion models. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Representativeness of the exposed cohort | Low risk | All UC patients who underwent colectomy from 2006 to 2016 |
Selection of the non exposed cohort | Low risk | Both groups obtained from the same hospitals and time period |
Ascertainment of exposure | Low risk | Patient charts reviewed |
Demonstration that outcome of interest was not present at start of study | Unclear risk | No information provided |
Comparability of cohorts (Controlled for critical factor/other medications) | High risk | Did not adjust for other medications |
Comparability of cohorts (Controlled for additional factor) | High risk | Did not adjust for additional factors |
Assessment of outcome | Low risk | Patient charts reviewed |
Was follow‐up long enough for outcomes to occur | Low risk | 30 days |
Adequacy of follow up of cohorts | Unclear risk | No information provided |