Summary of findings 1. Laparoscopic pyloromyotomy compared to open pyloromyotomy for pyloric stenosis.
| Laparoscopic pyloromyotomy compared to open pyloromyotomy for pyloric stenosis | ||||||
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Patient or population: infants (< 1 year of age) with hypertrophic pyloric stenosis Setting: inpatients Intervention: laparoscopic pyloromyotomy Comparison: open pyloromyotomy | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with open pyloromyotomy | Risk with laparoscopic pyloromyotomy | |||||
| Mucosal perforation | 8 per 1000 | 13 per 1000 (4 to 44) | RR 1.60 (0.49 to 5.26) | 720 (7 RCTs) | ⨁⨁◯◯ LOWa,b | The evidence suggests that laparoscopic pyloromyotomy may result in a small increase in mucosal perforation compared with OP, however the confidence interval around the effect estimate crosses the line of no effect. |
| Incomplete pyloromyotomy | 0 per 1000 | 0 per 1000 (0 to 0) | RR 7.37 (0.92 to 59.11) | 502 (4 RCTs) | ⨁⨁◯◯ LOWa,b | The evidence suggests that LP may result in higher rates of incomplete pyloromyotomy than OP, but the confidence interval around the effect estimate crosses the line of no effect. |
| Postoperative wound infection or abscess formation | 36 per 1000 | 21 per 1000 (9 to 53) | RR 0.59 (0.24 to 1.45) | 720 (7 RCTs) | ⨁◯◯◯ VERY LOWb,c | The evidence is very uncertain about the effect of laparoscopic pyloromyotomy on postoperative wound infection or abscess formation. |
| Postoperative incisional hernia | 5 per 1000 | 5 per 1000 (1 to 50) | RR 1.01 (0.11 to 9.53) | 382 (4 RCTs) | ⨁◯◯◯ VERY LOWb,d | The evidence is very uncertain about the effect of laparoscopic pyloromyotomy on postoperative incisional hernia. |
| Length of hospital stay | The mean length of hospital stay was 47.8 hours | MD 3.01 hours shorter (8.39 shorter to 2.37 longer) | ‐ | 562 (5 RCTs) | ⨁◯◯◯ VERY LOWe,f | The evidence is very uncertain about the effect of laparoscopic pyloromyotomy on length of hospital stay. |
| Time to full feeds | The mean time to full feeds was 27.7 hours | MD 5.86 hours shorter (15.95 shorter to 4.24 longer) | ‐ | 622 (6 RCTs) | ⨁◯◯◯ VERY LOWd,f,g | The evidence is very uncertain about the effect of laparoscopic pyloromyotomy on time to full feeds. |
| Operating time | The mean operating time was 25.9 minutes | MD 0.53 minutes longer (3.53 shorter to 4.59 longer) | ‐ | 622 (6 RCTs) | ⨁◯◯◯ VERY LOWd,f,h | The evidence is very uncertain about the effect of laparoscopic pyloromyotomy on operating time. |
| *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; RCT: randomised controlled trial; RR: Risk ratio; LP: laparoscopic pyloromyotomy; MD: Mean difference; OP: open pyloromyotomy; | ||||||
| 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 | ||||||
aNot downgraded for risk of bias because this is considered an objective outcome which is unlikely to be affected by performance bias. bDowngraded two levels for serious imprecision: few events and a 95% confidence interval that encompasses both potential benefit and potential harm from the intervention. cDowngraded one level for limitations in study design: three studies with high risk of selection bias, all studies with high risk of performance bias. dDowngraded one level for limitations in study design: two studies with high risk of selection bias, all studies with high risk of performance bias. eDowngraded two levels for serious limitations in study design: all studies at high risk of performance bias and outcome determined largely by surgeon. fDowngraded one level for imprecision: small sample size. gDowngraded one level for inconsistency: unexplained statistical heterogeneity I2 = 98%. hDowngraded one level for inconsistency: unexplained statistical heterogeneity I2 = 89%.