|
| Reference | Year | Group size calculation | Randomization and concealment of allocation | Blinding | Complete
followup | Risk of bias |
|
| Suzuki et al. [35] | 1995 | Missing | Drawing lots | Missing | Missing | High |
|
| Suzuki et al. [36] | 1999 | Missing | Drawing lots | Missing | Missing | High |
|
| Bassi et al. [37] | 1999 | Missing | Missing | Missing | Missing | High |
|
| Suc et al. [38] | 2003 | POPF rate 40%, reduction to 20%, one-tailed test alfa 5%, power of 80% | Telephone call to the coordinating center, computerized random-number tables | Patients and nursing staff | 30 days after discharge | Unclear |
|
| Oláh et al. [39] | 2009 | POPF rate 25%, reduction to 15%, alfa 5%, power of 80% | Sealed envelopes | Missing | Hospital stay | Low |
|
| Diener et al. [27] | 2011 | POPF rate 35%, reduction of 15%, two-sided alfa 5%, power of 80% | Central randomisation system | The patient and the outcome assessor | POD 30 | Low |
|
| Frozanpor et al. [24] | 2012 | POPF rate 40%, reduction to 0%, two-sided alfa 5%, power of 80% | Opaque sealed envelopes | Missing | POD 30 | Low |
|
| Hamilton et al. [40] | 2012 | POPF rate 20%, reduction to 5%, two-sided alfa 5%, power of 80% | Random number generator | The patient and the outcome assessor | POD 30 | Low |
|
| Montorsi et al. [41] | 2012 | POPF rate 30%, reduction to 15%, two-sided alfa 5%, power of 80% | Two separate randomization lists at each center (laparoscopic and open) | Missing | 2 months after discharge | Low |
|
| Carter et al. [21] | 2013 | POPF rate 30%, reduction to 15%, one-tailed test alfa 5%, power of 80% | Opaque sealed envelopes | Missing | May 2012 (7 months after trial closure) | Low |
|
