Summary of findings for the main comparison. Robotic‐assisted laparoscopic vs open radical cystectomy for bladder cancer in adults.
| Robotic‐assisted laparoscopic vs open radical cystectomy for bladder cancer in adults | |||||
| Patient or population: bladder cancer in adults Setting: tertiary care centres in the United States and the United Kingdom Intervention: robotic‐assisted laparoscopic cystectomy Comparison: open radical cystectomy | |||||
| Outcomes | No. of participants (studies) Follow‐up | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with open radical cystectomy | Risk difference with robotic‐assisted laparoscopic cystectomy | ||||
| Time to recurrence (here: recurrence rate at 5 years)1 assessed with clinical examination and imaging | 277 (2 RCTs) | ⊕⊕⊝⊝ LOWa,b | HR 1.05 (0.77 to 1.43) | Study population | |
| 431 per 1000 | 16 more per 1000 (79 fewer to 123 more) | ||||
| Major postoperative complications assessed with Clavien‐Dindo system (rated grade 3 to 5) | 541 (5 RCTs) | ⊕⊕⊝⊝ LOWb,c | RR 1.06 (0.76 to 1.48) | Study population | |
| 185 per 1000 | 11 more per 1000 (44 fewer to 89 more) | ||||
| Minor postoperative complications assessed with Clavien‐Dindo system (rated grade 1 or 2) | 423 (4 RCTs) | ⊕⊝⊝⊝ VERY LOWc,d | RR 0.82 (0.58 to 1.17) | Study population | |
| 443 per 1000 | 80 fewer per 1000 (186 fewer to 75 more) | ||||
| Transfusion rate assessed with transfused units of packed red blood cells | 326 (2 RCTs) | ⊕⊕⊕⊝ MODERATEc | RR 0.58 (0.43 to 0.80) | Study population | |
| 460 per 1000 | 193 fewer per 1000 (262 fewer to 92 fewer) | ||||
| Hospital stay assessed in days | 541 (5 RCTs) | ⊕⊕⊝⊝ LOWb,c | ‐ | Mean hospital stay ranged from 5.1 to 11.9 days | MD 0.67 days lower (1.22 lower to 0.12 lower) |
| Quality of life (higher scores indicate better quality of life) assessed with SMD calculated from various validated quality of life instruments Scale from 0 to 1 | 270 (3 RCTs) | ⊕⊕⊝⊝ LOWc,e | ‐ | Mean quality of life (higher scores indicate better quality of life) was 0 SD | SMD 0.08 SD lower (0.32 lower to 0.16 higher) |
| Positive margins assessed through pathological evaluation of cystectomy specimen | 541 (5 RCTs) | ⊕⊕⊝⊝ LOWb,c | RR 1.16 (0.56 to 2.40) | Study population | |
| 48 per 1000 | 8 more per 1000 (21 fewer to 67 more) | ||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; HR: hazard ratio; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio; SMD: standardised mean difference. | |||||
| 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. | |||||
1The control event rate at 5 years was based on an overall recurrence rate of 25/58 (43.1%) in the ORC arm reported in Bochner 2015
aDowngraded by one level for study limitations; risk of performance, detection, and attrition bias.
bDowngraded by one level for imprecision: wide confidence intervals consistent with both no effect and clinically important benefit or harm.
cDowngraded by one level for study limitations; risk of performance and detection bias.
dDowngraded by two levels for very serious imprecision: wide confidence interval consistent with small benefit, no effect, and small harm.
eDowngraded by one level for imprecision: wide confidence intervals consistent with both no effect and clinically important reduction in quality of life, assuming SMD of 0.2.