Kanyago 2013.

Study characteristics
Methods	Design: effectiveness RCT conducted in southwestern Uganda. Compared SR with FG male circumcision. 138 adult male students (≥ 15 years) attending a local university and undergoing male circumcision recruited from the surgical outpatient department. Ethical approval: Institutional Review Board Committee at Mbarara University of Science and Technology. Study registered with ClinicalTrials.gov (NCT01757938) Consent: participants provided written informed consent. Those who presented for circumcision but who did not consent to participate in the trial were offered standard FG adult male circumcision. Duration of study: January–May 2011
Participants	Inclusion criteria: adult male students attending Mbarara University (aged ≥ 15 years) who consented to participate in the trial. Exclusion criteria: self‐reported HIV infection, chronic paraphimosis, genital ulcers, penile carcinoma, filariasis, xerotica obliterans, balanitis, glans‐prepuce adhesions, frenula scar tissue, or any urethral anatomical abnormality such as hypospadias or epispadias. Baseline characteristics: median age of participants: 22 (interquartile range 21–23) years.
Interventions	Providers: single study surgeon performed all procedures; however, he had no prior experience with the SR procedure. Intervention group (SR): 73 participants. Appropriate size of SR ascertained. Penis disinfected using povidone‐iodine solution. Dorsal penile nerve block and circumferential block performed with 1% lidocaine. Follow‐up: assessed 1 hour after procedure, and on the 3rd, 7th, 14th and 21st postoperative days Control group (FG): 65 participants. Male circumcision performed using a standard technique. Follow‐up: not reported for control group
Outcomes	Primary outcomes: procedure time pain scores time to resumption of normal activity minor and major complications patient satisfaction time to complete healing Definitions for each were clearly outlined in the paper.
Funding sources	1 author, Mark J Siedner, received salary support from the Fogarty International Clinical Research Scholars and Fellows Program at Vanderbilt University (R24 TW007988), and the NIH (T32 AI007433).
Declarations of interest	SR devices supplied by an independent third‐party with no affiliation to Wuhu Santa Medical Devices Technology Co Ltd, China, who was not involved in the design, interpretation or writing of study.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Process for generating the randomization sequence not described; unclear risk of bias.
Allocation concealment (selection bias)	Low risk	Allocation concealment adequately reported; low risk of bias. Quote: "Consenting participants selected an opaque envelope from a box for randomisation to SR or FG groups."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding of participants and personnel was not possible with this surgical intervention; unclear whether this may have impacted the performance of either group.
Blinding of outcome assessment (detection bias) Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction)	High risk	No blinding of outcome assessment was done or was possible for the outcomes that were considered subjective. The presence of the non‐surgical intervention, an SR, until removal would increase the potential risk of bias in these subjective outcomes assessments.
Blinding of outcome assessment (detection bias) Objective outcomes (operative time)	Low risk	The lack of blinding was unlikely to have resulted in a detection bias for this objective outcome.
Incomplete outcome data (attrition bias) All outcomes	High risk	There was differential attrition in the 2 groups: 25% attrition in surgical group and 0% attrition in device group. Investigators suggested that the loss to follow‐up in the surgical group likely means that there were no adverse events to report (participants with adverse outcomes are likely to present to the clinic). However, the differential loss to follow‐up without clear reporting on the reasons for losses may have introduced a risk of bias. High risk of bias.
Selective reporting (reporting bias)	Low risk	Study protocol available on ClinicalTrials.gov (NCT01757938). All study's prespecified outcomes were reported.
Other bias	Low risk	No other biases identified.