Are circumcision devices safer or faster when compared to standard surgical circumcisions for males older than 10 years?

Background

Male circumcisions have been performed for many centuries and are one of the most common surgical procedures in males. Medical doctors usually perform circumcisions by removing the foreskin found on the penis in a surgical procedure. Some doctors use circumcision devices specifically designed for medical male circumcisions. It is believed that they may save time, and be simpler and safer circumcision methods. But, it is unclear from research evidence whether males circumcised with these devices have better health outcomes.

Study characteristics

After a wide search of the literature, we found 18 clinical trials including 5246 males. We looked at information from trials that compared surgical and device-based circumcision procedures. We compared the complications (negative experiences) that patients had after the circumcision; the amount of time a healthcare provider took to do the circumcision; patient's pain during the day after the procedure and one week afterwards; and the amount of satisfaction patients felt with the procedure.

Key results

There was probably little to no difference in serious complications (negative effects) such as admission to hospital or permanent damage to the penis in any trial whether men had a standard surgical circumcision or used a circumcision device.

There may be slightly more moderate complications that require additional treatment such as stitches or antibiotics for those circumcised with devices, but further evidence may help us understand this better.

We are unsure whether or not there is a difference in mild complications such as minor bleeding that requires added treatment, but further evidence may help us understand this better.

The average duration for the standard surgical procedure is about 24 minutes (ranging from 15 minutes to 31 minutes), compared to the use of circumcision devices that has an average duration of about 7 minutes (ranging from 3 minutes to 13 minutes). Therefore, the review found that using a circumcision device saved about 17 minutes compared to standard surgical circumcision.

There may be less pain during the first 24 hours in patients who were circumcised with the device compared to standard surgical circumcision. There may be little or no difference in pain in the first seven days after circumcision for patients who were circumcised with the device compared to those circumcised with standard surgical methods.

We found that patients were slightly more satisfied when circumcised with a device compared to those that received a standard surgical circumcision procedure.

Conclusions

Overall, our review found that circumcision devices may have slightly more complications than standard surgery, such as requiring antibiotics or stitches. We also found that procedures done with circumcision devices probably take less time to complete. Patients may feel less pain in the first 24 hours after a circumcision procedure when a device is used compared to the standard surgery. Patients may slightly prefer the use of a device compared to standard surgery. When deciding whether to use a device, these results should be kept in mind alongside consideration of the local context such as costs and access to trained healthcare workers in different healthcare settings. Further trials can help us to understand the benefits and harms with more certainty, particularly about complications and postoperative pain.

Authors' conclusions: 

We found that there were no serious adverse events reported when using a circumcision device compared to standard surgical techniques, but they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. Use of circumcision devices probably reduces the time of the procedure by about 17 minutes, a clinically meaningful time saving. For patients, use of the circumcision device may result in lower pain scores during the first 24 hours and patients may be slightly more satisfied with it compared with standard surgical techniques. Clinicians, patients and policymakers can use these results in conjunction with their own contextual factors to inform the approach that best suits their healthcare settings. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard approaches.

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Background: 

Medical circumcisions are among the most common surgical procedures performed in males. The usual indications are phimosis (inability to completely retract the foreskin and expose the glans due to a congenital or acquired constriction of the prepuce), paraphimosis (when the foreskin is not pulled back over the glans after retraction resulting in a tight constricting band which causes swelling of the distal penis and acute discomfort), balanoposthitis (erythema and edema of the prepuce and glans) and balanitis (inflammation is confined to the glans; the foreskin is usually non-retractile). Circumcision devices have been developed to shorten the operative time, simplify techniques, and improve safety and cosmetic outcomes. The devices generally aim to crush the foreskin while simultaneously creating hemostasis, the foreskin is then excised or allowed to slough off. Their use is supposedly safer and easier to replicate than the standard dissection techniques. There are at least 20 devices for male circumcision on the market, yet their effectiveness has not been reviewed to date.

Objectives: 

To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above).

Search strategy: 

We performed a comprehensive search with no restrictions to the language of publication or publication status. We searched the Cochrane Library, MEDLINE (PubMed), Embase, Web of Science, trials registries, grey literature sources and conference proceedings up to 16 April 2020.

Selection criteria: 

We included randomized controlled trials of device-based circumcisions (crush or ligature circumcision devices) compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting.

Data collection and analysis: 

At least two review authors independently assessed study eligibility and extracted data from the included studies. We classified adverse events into serious, moderate or mild. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals (CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome.

Main results: 

Eighteen trials met the inclusion criteria. Trials were conducted in China, South Africa, Kenya and Zambia, Mozambique, Rwanda, Uganda and Zimbabwe.

Primary outcomes

Serious adverse events: there were no serious adverse events in either treatment arm (11 trials, 3472 participants).

Moderate adverse events: there may be a slight increase in moderate adverse events when devices are used compared to standard surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I²= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more (ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We downgraded the certainty of the evidence for study limitations and imprecision.

Secondary outcomes

Mild adverse events: we are uncertain about the difference in mild adverse events between groups when devices are used compared to standard surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I² = 91%; 10 trials, 3370 participants; very low-certainty evidence). We downgraded the certainty of the evidence for study limitations, imprecision and unexplained inconsistency.

Operative time: operative time is probably about 17 minutes shorter when using a device rather than standard surgical techniques, which constitutes a clinically meaningful decrease in a procedure (MD –17.26 minutes, 95% CI –19.96 to –14.57; I² = 99%; 14 trials, 4812 participants; moderate-certainty evidence). We downgraded the certainty of the evidence for serious study limitations. The standard surgical technique generally takes about 24 minutes.

There may be less postoperative pain during the first 24 hours when circumcision devices are used compared to standard surgical techniques (measured using a visual analog scale [VAS]; MD 1.30 cm lower, 95% CI 2.37 lower to 0.22 lower; I² = 99%; 9 trials, 3022 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained heterogeneity. There may be little or no difference in postoperative pain experienced during the first seven days when compared with standard surgical techniques (measured using a VAS; MD 0.11 cm higher, 95% CI 0.89 lower to 1.11 higher; I² = 94%; 4 trials, 1430 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. A higher score on the VAS indicates greater pain.

Participants may slightly prefer circumcision devices compared to standard surgical techniques (RR 1.19, 95% CI 1.04 to 1.37; I² = 97%; 15 trials, 4501 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. We recorded satisfaction as a dichotomous outcome. Higher rates reflected greater satisfaction.

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