Yamamoto 2016.
Study characteristics | ||
Methods | Retrospective multicenter (7 institutions) cohort. Study period: 2008 to 2013 | |
Participants | Countries: Japan, Brazil and Italy. CD patients who underwent ileocolonic resection with primary anastomosis. Patients who had covering ileostomy or with insufficient data for analysis were excluded | |
Interventions | 1. Preoperative steroids (n= 68) 2. Preoperative immunomodulators (n= 65) 3. Preoperative biologics (n= 79) within 8 weeks of surgery 4. No preoperative steroids (n= 163) 5. No preoperative immunomodulators (n= 166) 6. No preoperative biologics (n= 152) |
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Outcomes | Anastomotic leak, intraabdominal abscess, fistula within 30 days of surgery | |
Notes | NOS low risk of bias overall Adjusted ORs for preoperative steroids, immunomodulators and biologics were obtained from multivariate analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Representativeness of the exposed cohort | Low risk | CD patients who underwent ileocolonic resection with primary anastomosis from 2008 to 2013 |
Selection of the non exposed cohort | Low risk | Both groups obtained from the same hospital and time period |
Ascertainment of exposure | Low risk | Data was obtained from a prospectively maintained database |
Demonstration that outcome of interest was not present at start of study | High risk | 43% of patients had perforating disease at baseline |
Comparability of cohorts (Controlled for critical factor/other medications) | Low risk | Controlled for steroids, immunosuppressants, biologics |
Comparability of cohorts (Controlled for additional factor) | Low risk | Also controlled for age, gender, behavior of CD, smoking, previous resections, blood transfusions, surgical approach and type of anastomosis |
Assessment of outcome | Low risk | Data was obtained from a prospectively maintained database |
Was follow‐up long enough for outcomes to occur | Low risk | 30 days |
Adequacy of follow up of cohorts | Low risk | Patients with insuffi ci ent data for analysis were excluded |