for the main comparison.
Nerve‐sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa) | ||||||
Patient or population: women with stage Ia2 to IIa cervical cancer Settings: University/Tertiary Hospitals Intervention: nerve‐sparing radical hysterectomy with pelvic lymph node dissection Comparison: standard radical hysterectomy with pelvic lymph node dissection | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Standard RH | Nerve‐sparing RH | |||||
Overall survival | see comment | see comment | (0 studies) | Survival was reported in two studies. No deaths were reported in the standard group and only two deaths in the nerve‐sparing group were reported so we could not calculate the HR (Table 2). | ||
Rate of ISC one month after operation | see comment | see comment | (0 studies) | No information reported in any of the included studies (see Effects of interventions). | ||
Time to PVR ≤ 50 mL (days) |
Mean 17.38 |
MD 13.21 lower (24.02 lower to 2.41 lower) |
MD ‐13.21 (‐24.02 to ‐2.41) | 111 women (2 studies) |
⊕⊕⊝⊝ Low1 | |
PVR one month after operation (mL) | Mean 80.25 |
MD 45.25 lower (59.81 lower to 30.69 lower) |
MD ‐45.25 (‐59.81 to ‐30.69) | 86 women (1 study) |
⊕⊕⊝⊝ Low1 | |
Perioperative complications (excluding bladder dysfunction) | 122 per 1000 |
55 fewer per 1000 (from 32 more to 93 fewer) |
RR 0.55 (0.24 to 1.26) |
180 women (3 studies) |
⊕⊕⊝⊝ Low1 | |
Disease‐free survival (median follow‐up: 101 months; range 13 to 137 months) |
50 per 1000 |
19 fewer per 1000 (50 fewer to 5,298 more) |
HR 0.63 (0.00 to 106.95) |
86 women (1 study) |
⊕⊝⊝⊝ Very low2 | Survival was reported in two studies. In one study, however there had been only one case with cancer recurrence so this precluded analysis of HR (Table 2). |
Quality of life | see comment | see comment | (0 studies) | One study reported quality of life but there had been inconsistency between the statement of the authors and reported data. So, we did not perform any analyses for this outcome (see Effects of interventions). | ||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
RH: radical hysterectomy; ISC: Intermittent self‐catheterisation; PVR: Postvoid residual volume of urine CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard ratio | ||||||
GRADE Working Group grades of evidence High‐certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate‐certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐certainty: We are very uncertain about the estimate. |
1 Unclear risk of selection/detection/performance biases and small sample size/non‐normally distributed data (‐2)
2Unclear risk of selection/detection/performance biases, small number of sample size and reported events, and applying unadjusted HRs in the analyses (‐3)