Aghamir 2012

Methods	Study design: parallel‐group randomised controlled trial. Setting: single centre/Iran. Dates when study was conducted: March 2010 to June 2011.
Participants	Inclusion criteria: age < 14, renal stone > 2.5 cm or renal stone with lesser diameter, and SWL failure. Exclusion criteria: kidney anomalies, renal failure on admission, serious bleeding or perforation in the collecting system during the operation. Diagnostic criteria: US or KUB and confirmed with IVU (spiral CT if sensitive to the dye — 5 patients). Total number of participants randomly assigned: 23. Group A (Standard PCNL) Number of participants randomly assigned: 10. Age (mean): 11.10 ± 1.72. Gender (M/F): 6/4. Group B (Tubeless PCNL) Number of participants randomly assigned: 13. Age (mean): 10.31 ± 2.68. Gender (M/F): 10/3.
Interventions	Group A (n = 10): standard PCNL — ureteral stent remained and a nephrostomy tube placed through the working sheath for 24‐48 hours. Group B (n = 10): tubeless PCNL — ureteral stent and sheath removed at end of procedure without placing a nephrostomy tube. Co‐interventions: standard bladder catheter.
Outcomes	Stone clearance How measured: considered as successful PCNL if there was no stone fragment remaining larger than 4 mm at sonography. Time points measured: at 24‐48 hours, at one week and one month after surgery. Time points reported: not reported. Subgroup: none. Complications How measured: postoperative evaluations included physical examination, lab tests (hemoglobin concentration and renal function tests), and imaging (abdominal and pelvic ultrasound and plain abdominal X‐ray). Time points measured: at 24‐48 hours after surgery. 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)	Unclear risk	Randomisation by envelopes. Randomisation sequence generation not clearly described.
Allocation concealment (selection bias)	Unclear risk	Quote from publication: "At the end of procedure, the randomised envelope was opened by circulating nurse and the patients were assigned to tubeless or control group". Unclear whether envelopes were sequentially numbered, opaque and sealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No knowledge of which procedure prior to intervention as envelope opened 'at the end of the procedure'. However, blinding might be broken due to presence of nephrostomy tube and different follow‐up schedule (additional visit for nephrostomy and ureteral stent removal).
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	All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment	Low risk	All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Secondary procedures	Low risk	All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Hospital stay	Low risk	All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Pain	Low risk	All randomised participants were included in the analysis.
Selective reporting (reporting bias)	High risk	Quote from publication: "Two unsuccessful cases with perforation and bleeding were excluded from the study". No published protocol available. Only stone‐free rate was prespecified, but all of the outcomes described in the result of article.
Other bias	Unclear risk	Additional visit for nephrostomy and ureteral stent removal might be necessary, but no information was given.