This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision (NCT01877408), a randomized na study. The primary outcome is Intraoperative Duration.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01877408 |
| Phase | NA |
| Condition | Circumcision |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 150 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Simunye Primary Health Care |
| Results posted | Yes |
2. Clinical Question
Population
Adult men undergoing voluntary circumcision. The registry record does not report further eligibility details or characteristics of the participants.
Intervention
Circumcision using the disposable Unicirc device to remove the foreskin, followed by wound sealing with tissue adhesive. The record describes this approach as intended to be performable by generalist doctors with minimal training.
Comparator
Open surgical circumcision, described as a commonly used technique in South Africa that requires good surgical skills. The registry record does not report the specific operative protocol or clinician experience in either arm.
Primary question
How did intraoperative duration compare between the two techniques? Duration was defined as the time from first manipulation of tissue under local anesthesia until dressing. The primary measure was the median, with interquartile range as the measure of spread, over a stated timeframe of 1 hour. The registry record does not report the observed duration results or a statistical comparison.
The broader stated aim was to identify a minimally invasive surgical circumcision technique that is easy to learn and perform, safe, and associated with high patient satisfaction and excellent cosmetic results. The listed secondary outcomes address learning and performing the technique, complete wound healing by post-surgery week 4, pain, overall patient satisfaction, and cosmetic result. These aims are broader than operative duration alone: they concern procedure performance, recovery, and participants’ reported or assessed experience. However, the registry record does not report results for these outcomes, nor does it describe how learning, pain, satisfaction, or cosmetic result were measured. The record identifies a comparison of procedures, not a reported conclusion about which approach performed better.
3. Trial Design
This was a randomized controlled trial with a parallel-group model and no masking. The registry record lists 150 participants enrolled and gives the trial status as completed. It identifies Simunye Primary Health Care as the sponsor. The recorded start was 2013-06, and primary completion was 2013-08. The phase is listed as NA. These entries describe registration and conduct status; they do not supply evidence about the clinical outcomes.
Participants were assigned to open surgical circumcision or to circumcision using the Unicirc device with tissue adhesive. The open technique is described as commonly used in South Africa and requiring good surgical skills, with minor complications common. The Unicirc approach couples foreskin removal with a disposable device and wound sealing with tissue adhesive; the description states that generalist doctors with minimal training can perform the procedure. These are descriptions of the interventions, not measured comparisons of operator skill or complication frequency in this trial.
Random allocation is intended to make the groups comparable on average, including on characteristics that are not measured. It does not ensure that groups are identical, and the reliability of a randomized comparison also depends on how the allocation sequence was generated and concealed. Those details are not reported in the registry record. Masking is listed as none, so the record does not describe masking of participants, clinicians, or outcome assessors. It does not say whether masking was infeasible for every outcome or whether any particular assessment was conducted without knowledge of treatment assignment.
The registry record lists 150 enrolled but does not provide a participant flow, the number who received each procedure, or the number included in analyses. The at-risk counts in the adverse-event information are 50 for open surgery and 100 for the device-and-adhesive group; they should be read as the denominators attached to those safety entries, not as a substitute for a full enrollment and analysis flow. Allocation ratio, study sites, eligibility criteria, follow-up procedures, and recruitment details are not reported in the registry record. The listed completed status indicates trial status, not that every outcome was measured or analyzed.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Healthy, uncircumcised men who were at least 18 years of age were eligible to participate in the study. All those who were enrolled and who showed up for their procedure were included in the study.
Overall Study
| Stage | Open Surgical Circumcision | Unicirc Device With Tissue Adhesive |
|---|---|---|
| STARTED | 50 | 100 |
| COMPLETED | 50 | 98 |
| NOT COMPLETED | 0 | 2 |
Reasons for not completing this period:
| Reason | Open Surgical Circumcision | Unicirc Device With Tissue Adhesive |
|---|---|---|
| Lost to Follow-up | 0 | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Open Surgical Circumcision | Unicirc Device With Tissue Adhesive | Total |
|---|---|---|---|---|
| Participants analysed | 50 | 100 | 150 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 49 | 100 | 149 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 50 | 100 | 150 |
| Region of Enrollment: South Africa | participants | 50 | 100 | 150 |
6. Primary Endpoint
The registry lists the primary outcome as Intraoperative Duration, measured over 1 hour.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | minutes |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was intraoperative duration, measured in minutes. It was defined as the time from the first manipulation of tissue under local anesthesia to application of the dressing. The stated timeframe was 1 hour. The registry record specifies the median as the summary measure and the interquartile range as the measure of dispersion.
Duration is a direct measure of procedure time. In a comparison of surgical techniques, it can describe how long the operation takes under the conditions in which it was performed. A median is useful when a distribution may be skewed or include unusually long procedures: it identifies the central point of the ordered observations without requiring the mean to represent the typical value. The interquartile range describes the spread of the middle portion of those observations. These are general statistical properties of the chosen summaries; they do not establish that the duration distribution in this trial was skewed.
Interpreting a difference in duration would require the observed medians and their uncertainty, along with information about the analysis population and any adjustment or testing approach. The registry record does not report the median duration, interquartile range, estimated between-group contrast, confidence interval, or p-value. It also does not report whether the recorded time was available for every enrolled participant. Therefore, the endpoint definition is clear enough to identify what was intended to be measured, but the posted results do not permit a statistical reading of the actual between-group duration.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of open surgical circumcision and circumcision using the Unicirc device with tissue adhesive. It specifies intraoperative duration as the primary outcome and lists additional outcomes covering learning and performing the technique, wound healing, pain, patient satisfaction, and cosmetic result. It does not report numerical results for those outcomes. In particular, no group medians, interquartile ranges, effect estimate, confidence interval, or p-value for duration are reported in the registry record. The listed secondary outcomes likewise have no posted results in the record.
That absence matters for interpretation. A trial design can describe what investigators intended to compare, but it cannot establish the direction, magnitude, or precision of an effect without outcome data. It is therefore not possible to tell from this record whether either technique had shorter recorded duration, how much the groups differed, or whether the data were compatible with a wide range of effects. Nor can the stated aim concerning ease of learning, safety, satisfaction, and cosmetic results be judged from aims alone.
Randomization provides a framework for a fair comparison, but the registry record does not report details of sequence generation, concealment, participant flow, or the analysis population. The trial is listed as unmasked. For a procedure comparison, knowledge of the assigned technique could influence care or assessment, depending on the outcome and safeguards used; the record does not describe such safeguards. These design considerations do not establish bias, but they limit how fully the comparison can be evaluated from the registry information.
The primary endpoint uses the median and interquartile range, but the record provides no values to interpret. These summaries would describe central tendency and spread; they would not, by themselves, give an uncertainty interval for the difference between groups. Because there is no reported contrast or uncertainty measure, statistical significance and clinical importance cannot be assessed. A p-value alone, even if reported, would not establish the size or practical importance of a difference; here, even that test result is not reported.
The registry record also indicates that the primary outcome was not reduced to one comparison because it has several categories or time points. Consequently, there is no single reported primary comparison to interpret from the information recorded. The count of listed outcome measures is 7, while the number of analyses is 0. These entries do not tell readers whether analyses were performed but not entered, whether results are available elsewhere, or whether particular outcomes were not analyzed. The registry record does not report that explanation. Overall, the record supports a description of the trial question and design, but not a conclusion about comparative outcome effects.
9. Statistical Methods Explained
The primary outcome is identified as duration in minutes, summarized by the median and interquartile range. These choices describe the distribution of observed procedure times. The median is the midpoint after observations are ordered, while the interquartile range expresses the span of the central half of the observations. General: these summaries can be more robust to extreme values than the mean and standard deviation. They do not show the precision of a between-group effect estimate, and they cannot replace a confidence interval for that contrast. No endpoint values or contrast estimates are reported in the registry record.
What does randomization contribute?
General: random allocation aims to prevent treatment assignment from being systematically determined by participant characteristics or prognosis. If allocation is implemented as intended, it supports a causal comparison because measured and unmeasured factors are balanced on average across groups. Chance imbalances can still occur, especially in a trial of limited size. Randomization does not resolve problems caused by missing outcomes, deviations from assigned treatment, outcome measurement, or selective reporting. The registry record labels allocation as randomized, but the sequence-generation and concealment methods are not reported. The recorded enrollment is 150; the record does not describe participant flow or establish how many participants contributed to each efficacy analysis.
Why does masking matter?
The masking entry is none. General: when participants or clinicians know the assigned intervention, expectations and behavior can differ between groups. For subjective outcomes such as pain or satisfaction, knowledge of treatment may affect reporting or assessment. For a measured duration, awareness of the technique could affect procedural behavior or timing practices. These are possible mechanisms, not evidence that bias occurred in this trial. The registry record does not state who assessed each outcome, whether timing was standardized, or whether any outcome-specific safeguards were used. Since the procedures differ visibly, masking may be difficult, but feasibility and actual practice are not reported in the registry record.
How should the absence of a reported contrast be read?
A between-group estimate describes the observed difference according to a defined analysis. A confidence interval describes the uncertainty around that estimate under the assumptions of the analysis. General: a narrow interval indicates greater precision than a wide interval, while an interval spanning effects in different directions may leave the direction uncertain. The registry record reports no estimate or confidence interval for duration. It also reports no p-value. Thus, neither effect size nor statistical uncertainty can be evaluated. The median and interquartile range, even if they had been posted separately by arm, would not automatically provide the uncertainty of a treatment contrast.
The primary outcome is noted as having several categories or time points and not reduced to one comparison. The registry record does not explain those categories or time points, so the scope of the intended primary analysis cannot be reconstructed. A clearly specified contrast ordinarily identifies the outcome, time point, comparison, and analysis population. Without that detail and the corresponding results, readers cannot determine which estimate would answer the primary question or how it relates to the recorded endpoint definition.
What is the role of the planning illustration?
The record describes planning assumptions based on a fraction of the observed effect: a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It states that non-time-to-event illustrations would be expressed as participants per arm for 80% power, while time-to-event illustrations would use a total event count based on the Schoenfeld method. These are planning conventions, not observed trial results or evidence of the trial’s achieved power. The registry record does not report a protocol sample-size justification, and the listed planning illustration is not the trial’s own design justification. No numerical planning output is reported in the registry record. Without a posted observed effect or outcome estimate, the assumptions cannot be translated into an independently interpretable illustration of precision or detectable effect.
Why can over-dispersion matter in general?
General: for count outcomes, over-dispersion means that the variability is greater than expected under a simple model such as the Poisson model. If it is ignored, standard errors can be too small and confidence intervals too narrow, making results appear more precise than warranted. The registry record does not identify a count outcome as the primary endpoint, describe a count model, or report an over-dispersion assessment. This concept is relevant only as a general statistical consideration; it is not a reported feature of this analysis.
In general, a complete interpretation also depends on prespecified analysis choices, handling of missing observations, and the relationship between planned and reported outcomes. Those details are not reported in the registry record. The available information therefore identifies some design features and a set of planning assumptions, but does not permit reconstruction of the statistical analysis or verification of its implementation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 7 outcome measures, including the primary duration endpoint and secondary outcomes concerning learning and performance, wound healing by post-surgery week 4, pain, overall patient satisfaction, and cosmetic result. It reports 0 analyses. These entries do not provide a multiplicity strategy, such as a hierarchy of outcomes, a designated confirmatory comparison, or an adjustment for testing several outcomes. The record does not explain whether the analysis count means no analyses were conducted or that analysis results were not entered. That explanation is not reported in the registry record.
General: testing multiple outcomes or multiple time points can increase the chance of obtaining at least one apparently notable result by chance if each is interpreted as a separate confirmatory test. A prespecified strategy helps readers distinguish the principal question from exploratory analyses. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison, but it does not provide details that would identify those categories or show how multiplicity was handled. No adjustment method or interpretation framework is reported.
Missing-data handling is also not reported in the registry record. There is no account of participants lost to follow-up, incomplete duration measurements, exclusions after randomization, or imputation methods. The analysis population is not stated: the record does not identify whether analyses were intended to follow randomized assignment, include only participants who received the procedure, or use another definition. General: these choices can affect both the size and interpretation of a treatment comparison, especially when missingness or exclusions differ by group. Without participant flow and analysis-population definitions, it is not possible to assess the potential effect of missing data or departures from assigned treatment.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Open Surgical Circumcision | 0 | 50 | 0.0% |
| Unicirc Device With Tissue Adhesive | 0 | 100 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Open Surgical Circumcision | 9 of 50 |
| Unicirc Device With Tissue Adhesive | 28 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Open Surgical Circumcision | Unicirc Device With Tissue Adhesive |
|---|---|---|---|
| Post-operative infection | Surgical and medical procedures | 6 of 50 | 10 of 100 |
| Moderate post-operative bleeding | Surgical and medical procedures | 2 of 50 | 10 of 100 |
| Mild post-operative bleeding | Surgical and medical procedures | 1 of 50 | 4 of 100 |
| Hematoma | Surgical and medical procedures | 0 of 50 | 4 of 100 |
The adverse-event entries list 0 participants affected by serious events among 50 at risk in the open surgical circumcision group, and 0 among 100 at risk in the Unicirc device with tissue adhesive group. For other, non-serious adverse events, the record lists 9 affected among 50 at risk in the open surgery group and 28 among 100 at risk in the device-and-adhesive group. These are the counts recorded for the safety entries; they should not be treated as a complete description of event types or severity.
The registry record does not list serious-event terms, and it does not report the definitions used for serious or other adverse events, the observation period, or whether participants could experience more than one event. Deaths are not reported in the registry record. The groups’ at-risk denominators describe the safety entries but do not supply a full account of exposure, follow-up, or missing safety information.
General: a recorded count of zero serious events does not prove that the true risk is zero. It means no affected participants were recorded in those entries. Small or incomplete safety datasets may not characterize uncommon events precisely. The other-event counts cannot establish comparative safety without details on event definitions, follow-up, and analysis. These registry figures should be read descriptively, not as a complete safety assessment.
12. What the Result Does, and Does Not, Mean
The registry record is informative about the question the trial set out to address. It identifies a randomized comparison between open surgical circumcision and a procedure using the Unicirc device with tissue adhesive, and it defines intraoperative duration as the primary outcome. It also records outcomes related to learning, healing, pain, satisfaction, and cosmetic result. These elements help establish what the investigators intended to study.
They do not establish which procedure had a shorter duration or how the procedures compared on healing, pain, satisfaction, cosmetic result, or complications. The primary outcome results are not reported in the registry record, and the listed secondary outcomes have no reported estimates. Without observed effect estimates and measures of uncertainty, there is no basis in this record for judging the direction, magnitude, or precision of comparative effects. The stated purpose and intervention descriptions are not substitutes for outcome evidence.
The safety entries record no participants affected by serious adverse events in either group, alongside counts for other adverse events. Those entries are limited by the absence of event terms, definitions, follow-up details, and reported death information. They should not be taken to show that serious harm is impossible or to characterize the full safety profile. Likewise, the description that the device-based procedure can be performed by generalist doctors with minimal training is an intervention description, not a reported trial result demonstrating learning performance.
General: statistical evidence is most useful when the effect estimate is read together with its uncertainty, the endpoint definition, and the analysis population. A reported p-value, if one were available, would not by itself show whether an effect was large, precise, or practically important. In this record, no p-value or effect estimate is reported for the primary outcome. The appropriate conclusion is therefore limited: the registry describes a completed randomized trial and its planned comparison, but does not provide enough outcome results to determine what the observed comparative effects were.
The trial’s completion status does not resolve these gaps. It indicates that the registry lists the study as completed, not that every planned outcome was collected, analyzed, or reported. Further details on outcome results and analysis methods are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized comparison of two procedural approaches with a direct timing endpoint and a broader set of patient- and procedure-related outcomes. The primary measure, median intraoperative duration with interquartile range, describes the center and spread of procedure times without requiring a mean-based summary. The listed secondary outcomes make clear that evaluation of a technique can involve more than operating time: the record also identifies learning and performance, wound healing, pain, satisfaction, and cosmetic result.
The design also raises interpretive issues that are common in procedural trials. The trial is listed as randomized, but sequence generation and allocation concealment are not reported. Masking is listed as none. For some outcomes, especially those involving judgment or self-report, awareness of the procedure can be relevant to measurement. These considerations are not evidence that the trial’s results are biased; they identify information that would be needed to evaluate how the comparison was conducted.
The registry record’s statement that the primary outcome was not reduced to one comparison because it has several categories or time points is important for statistical interpretation. A trial question is clearest when the key outcome, time point, contrast, and analysis are identifiable. The record does not explain the categories or time points or provide an analysis result. The listing of 7 outcome measures and 0 analyses further means that readers cannot assess how reported findings would relate to the full set of planned outcomes.
Finally, the available safety counts illustrate why event counts need context. Counts of participants affected are useful descriptive entries, but event definitions, observation time, and complete participant flow are also needed to understand safety comparisons. Overall, the statistical importance of this trial lies in its clear procedural comparison and its multiple outcome domains, alongside substantial limits in the results and methods information recorded. The registry supports understanding the design, not a conclusion about comparative effectiveness or safety.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific details needed to interpret the comparison are not reported in the registry record. Eligibility criteria, baseline participant characteristics, study sites, recruitment procedures, and the number of participants who received each intervention are not described. Although enrollment is listed as 150, there is no participant flow showing exclusions, withdrawals, or follow-up completion. The adverse-event denominators are recorded as 50 and 100, but the record does not explain how those safety populations relate to the randomized or analyzed populations.
The registry record does not report the method used to generate or conceal random allocation. The allocation ratio and any stratification or blocking are not specified. Masking is listed as none, but the record does not identify who assessed each endpoint or how subjective assessments were standardized. This matters particularly for listed outcomes such as pain, satisfaction, and cosmetic result, for which assessment methods can influence interpretation.
Outcome reporting is incomplete for statistical interpretation. The duration results, including the median and interquartile range, are not reported, and no between-group estimate, confidence interval, or p-value is recorded. Secondary outcome results are also not reported. The record notes that the primary outcome was not reduced to one comparison because it has several categories or time points, without specifying those categories or time points. It does not report analysis populations, missing-data methods, protocol deviations, or a multiplicity approach.
Safety information is limited to affected-participant counts. Adverse-event definitions, event terms, follow-up period, exposure, and death information are not reported in the registry record. The intervention descriptions mention that minor complications are common with open surgery, but the record does not provide a trial-based comparison that would quantify or contextualize that description. These limitations prevent a complete assessment of outcome reliability, precision, and generalizability from the registry information alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision — NCT01877408.
- Registry record last updated 2018-10-02; status last verified 2018-09.
- Results first posted 2014-02-06.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, parallel-group trial with no masking, comparing open surgical circumcision with the Unicirc device and tissue adhesive. Enrollment is listed as 150, with the recorded start in 2013-06 and primary completion in 2013-08. The primary outcome was intraoperative duration in minutes, summarized by median and interquartile range, with a stated timeframe of 1 hour.
Secondary outcomes include learning and performing the technique, complete wound healing by post-surgery week 4, pain, overall patient satisfaction, and cosmetic result. The adverse-event entries list 0 serious-event participants in both groups and record other adverse events among participants at risk. Numerical results for the primary endpoint and analyses of the listed outcomes are not reported in the registry record. The design and aims are identifiable, but comparative effects and their precision cannot be evaluated from the posted registry information.