Celdran 2004.
Methods | Study: prospective, randomised. Allocaton: number list. Blinding: yes | |
Participants | 99 patients: 50 P / 49 C. | |
Interventions |
Hernioplasty ATB: cephazolin 1 gr. MA: 30 minutes before the incision. Control: placebo |
|
Outcomes | IP= 0; IC= 4 | |
Notes | The interim analysis, performed after the first 91 patients had been included, recommended ending the study due to ethical reasons. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A list of random numbers was generated to assign the treatment." |
Allocation concealment (selection bias) | High risk | Quote: "A prospective, double‐blind trial was performed ..." Comment: Probably not done. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned. Comment: Probably not done. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned. Comment: Probably not done. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All patients were examined 1 week, 1, 3, and 6 months, and 1 and 2 years postoperatively by trained impartial surgeon." |