| Methods |
Study design: parallel‐group randomised controlled trial. Setting: single centre/India. Dates when study was conducted: March 2012 to September 2013. |
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| Participants |
Inclusion criteria: age < 15 years and single radio‐opaque lower calyceal calculus 1‐2 cm. Exclusion criteria: bleeding disorders, radiolucent stones, active urinary tract infection, severe hydronephrosis, unfit for anaesthesia, serum creatinine > 1.5 mg/dL, anatomically abnormal kidney and co‐existing ureteral pathology including tumour/stricture. Diagnostic criteria: USS KUB, radiography of the KUB to assess radiopacity of the calculus, IVU. CT in some cases to assess the pelvicaliceal anatomy including lower caliceal infundibulopelvic angle, degree of hydronephrosis, and urinary drainage pattern. Total number of participants randomly assigned: 221. Group A (SWL)
Group B (Mini PCNL)
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| Interventions |
Group A (n = 111): SWL (5 patients lost to follow‐up (106 included in analysis). Outpatient procedure using the electromagnetic lithotripter (Dornier Alpha Compact system, Wessling, Germany). Shockwave delivery rate 90 pulses per minute. Group B (n =110): Miniperc (4 patients lost to follow‐up (106 included in analysis). One experienced consultant and under general anaesthesia. Co‐interventions: double J stent and nephrostomy in PCNL. |
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| Outcomes |
Stone clearance
Complications
Secondary procedures
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| Notes |
Funding Sources: not stated Declaration of interests: no competing financial interests exist. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: 'Using a computer generated randomisation table, the eligible patients were randomised into two groups: Groups A, patients who underwent mini‐perc, and group B, patients who underwent SWL.' |
| Allocation concealment (selection bias) | Unclear risk | Not described by the authors. No clarification regarding open or concealed randomisation schedule. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Objective outcomes are not likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) Stone free rate | Low risk | 5/111 (4.5%) and 4/110 (3.6%) participants in SWL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment | Low risk | 5/111 (4.5%) and 4/110 (3.6%) participants in SWL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Secondary procedures | Low risk | 5/111 (4.5%) and 4/110 (3.6%) participants in SWL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Hospital stay | Low risk | 5/111 (4.5%) and 4/110 (3.6%) participants in SWL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Pain | Unclear risk | No information given. |
| Selective reporting (reporting bias) | Unclear risk | The outcomes were not prespecified and no published protocol available. |
| Other bias | Low risk | Not detected |