| Methods |
Study design: parallel‐group randomised controlled trial. Setting: single centre/China. Dates when study was conducted: September 2009 to September 2012. |
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| Participants |
Inclusion criteria: renal calculi confirmed by spiral CT, 7‐36 months old, stone diameter < 4.5 cm, no previous SWL. Exclusion criteria: renal anatomical abnormalities, ureteropelvic junction stenosis, pyonephrosis combined with stones, or isolated kidney. Diagnostic criteria: US, spiral CT, IVU. Total number of participants randomly assigned: 78. Group A (Standard PCNL)
Group B (Tubeless Mini PCNL)
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| Interventions |
Group A (n = 38): in PCNL, the method of surgery was the same, except post procedure the nephrostomy tube was inserted. Group B (n = 40): in MPCNL 18 G (gauge) biopsy needle was inserted at the posterior axillary line, the ureteral catheter was expanded by a fascia dilator to F14 or F16 while the sheath was left in place. The paediatric nephroscope or ureteroscope was then inserted, and the stones were smashed by holmium laser and picked out by clamps or washed out by lavage fluid. Co‐interventions: ureteral and Foley catheters. |
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| Outcomes |
Stone clearance
Complications
Secondary procedures
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| Notes |
Funding Sources: not stated Declaration of interests: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "Preschool children were randomised into MPCNL and standard PCNL groups by generation of a random number table". |
| Allocation concealment (selection bias) | Unclear risk | Quote from publication: "Surgical nurses randomly selected an envelope containing each patient's group". Unclear whether envelopes were sequentially numbered, opaque and sealed. |
| 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 | Unclear risk | 3/38 (7.8%) and 5/40 (12.5%) participants in PCNL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment | Unclear risk | 3/38 (7.8%) and 5/40 (12.5%) participants in PCNL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Secondary procedures | Unclear risk | 3/38 (7.8%) and 5/40 (12.5%) participants in PCNL and mini‐PCNL group were not included in the analysis, respectively. |
| Incomplete outcome data (attrition bias) Hospital stay | Unclear risk | No information given. |
| 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. |
Abbreviations
CT: computerised tomography; DUS: distal ureteric stone; IVU: intravenous urethrogram; KUB: kidney ureter bladder; MPCNL: mini percutaneous nephro lithotomy; NCCT: non‐contrast computerised tomography; RIRS: retrograde intrarenal surgery; SWL: shock wave lithotripsy; TUL: trans‐urethral lithotripsy; ULT: ureteroscopic lithotripsy; URS: ureteroscopy; US/USS: ultrasound; XR: x‐ray.