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. 2018 Jun 2;2018(6):CD010784. doi: 10.1002/14651858.CD010784.pub2
Methods Study design: parallel‐group randomised controlled trial.
Setting: single centre/China.
Dates when study was conducted: September 2009 to September 2012.
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)
  • Number of participants randomly assigned: 38.

  • Age (mean): 20.10 ± 7.22 months.

  • Gender (M/F): not reported.


Group B (Tubeless Mini PCNL)
  • Number of participants randomly assigned: 40.

  • Age: 20.30 ± 6.35 months.

  • Gender (M/F): not reported.

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.
Outcomes Stone clearance
  • How measured: CT or B‐mode US. Residual stones of ≤ 4 mm were considered negligible.

  • Time points measured: at 1,3,6 and 12 months postoperatively.

  • Time points reported: reported in counts and percentages but no time points.

  • Subgroup: none.


Complications
  • How measured: perioperative evaluation.

  • Time points measured: some during surgery, some not reported.

  • Time points reported: not reported.

  • Subgroup: none.


Secondary procedures
  • How measured: not reported.

  • Time points measured: not reported.

  • Time points reported: not reported.

  • Subgroup: none.

Notes Funding Sources: not stated
Declaration of interests: not stated
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.