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. 2021 Mar 31;2021(3):CD012250. doi: 10.1002/14651858.CD012250.pub2

Lv 2014.

Study characteristics
Methods Design: prospective RCT conducted at 5 different hospitals in China. Compared conventional circumcision vs SR vs DCSD. 942 participants from 5 hospitals.
Ethical approval: ethics committee (number: 2012‐Research‐52)
Consent: participants provided written informed consent.
Duration of study: October 2012 to May 2013
Participants Inclusion criteria: men requiring circumcision for a redundant prepuce or phimosis.
Exclusion criteria: ages < 18 years, dense adhesions between glans and foreskin and obese men with partly buried penis.
Baseline characteristics: mean age across groups: 31.5 (SD 5.4; range 18–58) years. No significant age differences between groups (P > 0.05). No other comments were made regarding other characteristics evaluated across groups. Mean age of both groups combined was 31.5 (SD 5.4) years,  age ranging between 18 ‐ 58 years.
Interventions Providers: 1 experienced surgeon who had performed conventional and SR circumcisions and was trained to use the devices before the study began was chosen from each of the 5 hospitals.
Intervention group 1 (DCSD): 314 participants. 5% lidocaine cream was used for anesthesia. The device had bell‐shaped glans pedestal, suture staple, ring‐shaped blade, handle and shell. The glans was covered by the U‐shaped glans rest with the edge of the U‐shape at the level of the coronary sulcus. After the foreskin was wrapped around the rod, the rod was inserted into the center hole of the circumcision device. The application knob was tightened, the safe buckle was removed and the rod was pushed down to trigger the circumcision device. After triggering the application knob when the ring‐shaped blade hidden in the shell was pushed out with the staples. The blade cut the foreskin instantly, while simultaneously placing staples, by tightening the application knob at the bottom for 3–5 seconds and releasing it.
Intervention group 2 (SR): 314 participants. 2% lidocaine injection (10 mL) for dorsal penile nerve block and a suitable sized device used.
Control group (conventional): 314 participants. 2% lidocaine injection (10 mL) for dorsal penile nerve block and a traditional electrosurgical knife and absorbable suture used.
Follow‐up: 1 and 2 weeks, and 1 month after for all groups
Outcomes Primary outcomes:
  • postoperative complications (hematoma, edema, disruption of incision, incision infection)

  • healing time

  • intraoperative and postoperative pain

  • intraoperative blood loss

  • operation time

  • patient satisfaction


Definitions for each were clearly outlined in the paper.
Funding sources Jiangxi Yuansheng Lang He Medical Instrument Co., Ltd. for the equipment and technique provided.
Declarations of interest Authors declared no competing interests.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table used to develop random sequence.
Allocation concealment (selection bias) Unclear risk No information about the process for ensuring allocation concealment.
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.
No information provided regarding blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction) High risk Outcome assessment was unblinded and would most likely result in detection bias for the subjective outcomes.
The researchers attempted to standardize outcome assessment for adverse effects, as it stated in the paper.
Quote: "we defined assessment standards for incision healing: the incision is closed and covered by skin, no rupture under moderate exercise; with time, the healed incision can withstand certain stretching force and pressure, the pigmentation is relieved and is close to the color of normal skin; return to the intact normal skin function."
Comment: despite this, as outcome detection still had an element of subjectivity; high risk of detection bias.
Blinding of outcome assessment (detection bias)
Objective outcomes (operative time) Low risk Lack of blinding was unlikely to affect the outcomes assessment of operative time, which we considered an objective outcome.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants randomized were included in the analysis of all outcomes.
Selective reporting (reporting bias) Unclear risk No study protocol. Therefore, unclear whether there may have been selective outcome reporting. No mention of clinical trials database registration.
Other bias Low risk No other biases identified.