The safety of stapler circumcision is one of the most frequently analyzed aspects of this minimally invasive method. A pilot, randomized clinical trial conducted in two centers and published in Medical Science Monitor compared a new disposable circumcision device with the conventional dissection technique (CDT) in 120 men.
Methodology: randomization, 2 centers, 120 men
The study included 120 adult men (mean age 26.6 years) with redundant foreskin or phimosis, treated between 2011 and 2012 in two Chinese hospitals. They were randomly assigned to two groups of 60 people:
- device group — circumcision with a disposable stapler (glans-protecting rod, circular blade + simultaneous wound closure with staples),
- control group — classic dissection technique (CDT) with electrocoagulation and absorbable sutures.
Intraoperative bleeding, operation time, pain, healing, satisfaction, and adverse events were assessed. The study received approval from the bioethics committee, and the device had registration and certifications.
Results: faster, less blood, no adverse events
| Parameter | Stapler | Classic method (CDT) | Significance |
|---|---|---|---|
| Procedure time | 7.6 min | 23.6 min | p0.01 |
| Intraoperative bleeding | 3.5 ml | 13.1 ml | p0.01 |
| Adverse events | 0 | 0 | — |
| Procedure effectiveness | 96,7% | 100% | — |
| Full satisfaction (day 14) | 95% | 95% | p>0.05 |
The stapler shortened the procedure by approximately 3 times and reduced bleeding by approximately 4 times. No adverse events (hemorrhage, wound dehiscence, infection) were reported in either group.
Staples fell off spontaneously
In the stapler group, most staples fell off spontaneously, and the wound was covered with epithelium. Only 9 out of 58 patients required manual removal of residual staples (day 14). This shows that the device’s design genuinely influences whether the staples detach on their own.
Equivalent comfort and satisfaction
In terms of postoperative pain, healing, and satisfaction, the results were statistically equivalent to the classic method (p>0.05). On day 14, 95% of patients in both groups reported full satisfaction, with not a single “dissatisfied” rating.
Limitations – Honestly
This was a pilot study on a relatively small sample (120), without blinding. The authors themselves emphasize that rare adverse events require confirmation in larger studies. Two conversions to the classic method were noted, hence an effectiveness of 96.7%.
Anastomat ZSR 2.0 in light of this data
Anastomat ZSR 2.0 belongs to the class of disposable circumcision staplers evaluated in this study — with a glans-protecting rod, a circular blade, and simultaneous wound closure with staples. Subsequent generations refine the spontaneous detachment of staples, partly through a silicone healing ring.
View Anastomat ZSR 2.0 specifications → | Schedule a consultation →
Conclusions
A pilot RCT confirmed that the disposable circumcision stapler is significantly faster and less bloody than classic surgery, with equivalent comfort, healing, and satisfaction, and no adverse events. Its ease of use makes it an attractive, repeatable alternative.
Source: Jiang M, Wang J, Zhou Y, et al. Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers. Med Sci Monit. 2014;20:454–462.
Content intended for medical professionals; does not replace individual clinical assessment.
Sources
- Wang J, Zhou Y, Xia S, Zhu Z, Jia L, Liu Y, Jiang M. Safety and efficacy of a novel disposable circumcision device: a pilot randomized controlled clinical trial at 2 centers. Med Sci Monit. 2014;20:454–462. doi:10.12659/MSM.889722. View publication
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