A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision (NCT01688310), a randomized na study. The primary outcome is Intraoperative Duration.

2. Clinical Question

The question is about procedure duration, not a broad comparison of every potential benefit or harm. The primary measure captures the time spent from the stated starting point through dressing. It therefore concerns the intraoperative process, rather than time to healing or later recovery.

The record also names difficulty learning and performing the technique, time required for healing, direct costs, pain, overall patient satisfaction, and cosmetic result as secondary outcomes. Among posted secondary results, pain experienced two days after surgery has numerical arm-level results. The registry record does not report numerical results for the other named secondary outcomes.

The trial was randomized and parallel, with open surgical circumcision as the control arm. Masking was listed as none. This comparison can describe the observed difference between assigned procedure groups, but its interpretation depends on the methods used to collect and analyze each outcome. Details beyond those recorded, including how participants were selected and how allocation was implemented, are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group trial with a registry enrollment of 200. It is listed as completed. The record lists the phase as NA and identifies Surgical Technique as the condition. The sponsor was Universidade Católica de Moçambique. The registered study dates are 2012-08 for study start and 2013-03 for primary completion.

The two procedures were open surgical circumcision and Gomco clamp circumcision with tissue adhesive. The arm descriptions distinguish the open technique, which the record says requires good surgical skills and has common minor complications, from the Gomco technique, described as removal of the foreskin followed by wound sealing with adhesive. These are descriptions of the procedures in the registry, not independently established findings about ease, safety, healing, or cost.

Allocation was randomized, the model was parallel, and masking was listed as none. No additional information about the randomization sequence, concealment, stratification, or implementation is reported in the registry record. The record does not report whether outcome assessors were masked; the overall masking entry is none.

The primary outcome was intraoperative duration, expressed as a mean in minutes with standard deviation. It was defined as the time from the first manipulation of tissue under local anesthesia to dressing, and the population was listed as all participants. Although a timeframe of 1 year is recorded for the primary outcome, the measurement definition itself describes procedure duration. Further detail explaining that timeframe is not reported in the registry record.

The registry lists secondary outcomes spanning learning and performance, healing time, direct costs, pain, satisfaction, and cosmetic result. It lists six posted secondary outcomes, but numerical results are available in the posted results for pain. The record lists eight outcome measures overall. The original sample-size rationale, planned statistical analysis, and any interim analyses are not reported in the registry record.

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: 241 interviewed, Excluded (n=41) * Inclusion criteria not met (n=19) * Under 18 years of age (n=17) * Phimosis (n=2) * Declined to participate (n=22) 200 were randomized and underwent circumcision in the arm allocated

Overall Study

Analysis population for the primary outcome, as defined in the registry: All participants

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.

6. Primary Endpoint

The registry lists the primary outcome as Intraoperative Duration, measured over 1 year.

The primary endpoint is intraoperative duration: the time from the first manipulation of tissue under local anesthesia until dressing. It is measured in minutes and summarized as a mean with standard deviation for all participants. The registry records a timeframe of 1 year, alongside this procedure-based measurement definition; it does not explain the relationship between the timeframe and the measurement in further detail.

Duration is useful for describing the time associated with performing the two procedures. Comparing group means gives a summary of average procedure time, while the standard deviations describe the observed spread of times within each group. Neither summary captures every individual experience: a mean can be influenced by the distribution of values, and a standard deviation does not describe the full shape of that distribution.

As a general statistical point, a clearly defined endpoint supports a focused comparison because the starting and ending points specify what is being timed. The definition does not include later healing, patient satisfaction, or pain; those are distinct outcomes. The result therefore answers a process question about the duration measure, and should not be treated as a summary of all the outcomes named in the registry.

7. Results Posted in the Registry

• Gomco Clamp With Tissue Adhesive: mean 12.80 versus 22.50 on control; difference -9.70 (95% CI -11.10 to -8.30), standardized effect d = -1.92; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Pain Experienced

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Gomco Clamp With Tissue Adhesive: mean 1.80 versus 2.50 on control; difference -0.70 (95% CI -1.19 to -0.21), standardized effect d = -0.40; z-test p = 0.005.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Gomco Clamp With Tissue Adhesive than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry names secondary outcomes covering technique learning and performance, healing time, direct costs, pain, overall patient satisfaction, and cosmetic result. The posted numerical secondary result is pain experienced two days after surgery. Numerical results for the other named outcomes are not reported in the registry record. This means the secondary outcome list describes the scope of the intended questions, but does not offer a numerical basis for comparing every aspect of the procedures.

The pain comparison concerns a different dimension from the primary result. Intraoperative duration captures time during the procedure, whereas pain is a patient-reported measure recorded two days after surgery. A difference in one outcome does not by itself predict or explain a difference in another. The results are related in the broad sense that both compare the randomized procedure groups, but each addresses a separate outcome and has its own measurement and analysis considerations.

Secondary results generally carry less weight than a primary result when the registry does not document a hierarchy, a multiplicity plan, or a complete analysis strategy. Testing several outcomes can increase the chance that at least one result appears notable by chance. This is a general statistical concern, not evidence that a particular secondary finding is false. The record does not report adjustment for multiple comparisons or explain how secondary outcomes were prioritized.

The appropriate reading is therefore outcome-specific: the posted pain estimate is an observed secondary comparison, while conclusions about healing, costs, learning, satisfaction, and cosmetic result cannot be drawn from numerical results that are not reported in the registry record. The primary duration result remains the designated main comparison, but it does not substitute for the missing secondary outcome information.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Difficulty in Learning and Performing Technique
• Time Required for Healing
• Direct Costs
• Pain Experienced
• Overall Patient Satisfaction
• Cosmetic Result

9. Statistical Interpretation

10. Statistical Methods Explained

The registered design is a randomized parallel comparison. Each participant was assigned to one of two procedure groups, and the outcome summaries are reported by arm. Randomization is intended, in general, to make the groups comparable on average at the point of assignment. It does not guarantee that every measured or unmeasured characteristic is balanced in a particular trial. Details of the sequence generation, allocation concealment, and checks of baseline comparability are not reported in the registry record.

What does a mean difference represent?

The primary endpoint is continuous: it records duration in minutes. The registry reports a mean for each arm and a mean difference comparing Gomco with open surgical circumcision. The posted arm means are 22.5 and 12.8 minutes, respectively, and the posted mean difference is -9.7 minutes. The direction is important: a negative estimate means the Gomco mean is lower when the comparison is defined as Gomco minus open surgical circumcision.

A mean difference stays in the original measurement units, so it can be interpreted as a difference in average minutes. It does not mean that every participant in one group had a shorter procedure than every participant in the other group. Individual durations can vary within each arm. The standard deviations, 6.6 and 2.7, provide a measure of that variation around the respective means, but do not show all features of the distributions.

What does the confidence interval contribute?

A confidence interval gives a range of estimates compatible with the data and the method used to calculate it. In general, it helps show precision as well as direction: a narrower interval indicates more precision than a wider interval on the same scale. The primary interval runs from -11.1 to -8.302 minutes. The posted range does not cross zero, so the estimated direction remains negative throughout that interval. An interval does not show the probability that the true value lies within it, and its interpretation depends on the calculation method and assumptions.

The registry record does not specify the confidence level or provide the statistical analysis plan. It also does not state whether the primary comparison used adjustments, handled protocol deviations in a particular way, or included all randomized participants in the analysis. The posted population field says all participants, but further details about the analyzed population are not reported in the registry record.

How should the p-value be read?

The primary unadjusted p-value is < 0.001. In general, a p-value describes how incompatible the observed data, or data more extreme, would be with a specified null model if the model and assumptions held. It is not the probability that the null hypothesis is true, nor a measure of the magnitude or importance of the difference. The registry does not report the test statistic, test procedure, or whether any planned adjustments were applied, so the p-value should be interpreted as the posted unadjusted result rather than as a complete account of the analysis.

For pain, the posted unadjusted p-value is 0.005. That is a secondary comparison. When multiple outcomes or comparisons are considered, the chance of obtaining at least one apparently unusual result can increase if no adjustment or interpretation plan is used. Whether and how multiplicity was addressed is not reported in the registry record. Consequently, the secondary p-value should not be interpreted as if it were the only statistical test performed.

Why does variability matter?

For a continuous outcome, the mean alone does not convey how spread out observations are. Standard deviations give a scale for the within-arm variability and are part of understanding how much individual measurements differ around the group mean. General statistical reasoning also distinguishes variability among participants from uncertainty about an estimated mean or difference. The latter depends on both variability and the amount of data contributing to the estimate, along with the analysis method. The registry reports standard deviations and arm sizes for the posted outcomes, but does not describe missing observations or the exact computation of the confidence intervals.

For other outcomes, the appropriate analysis can differ. A time-to-healing outcome, for example, can involve both the time until an event and participants whose event is not observed within follow-up. In general, methods for censored time-to-event data account for that feature rather than treating all observations as ordinary continuous measurements. The registry names time required for healing as a secondary outcome, but numerical results and analysis details for it are not reported in the registry record. This is a general methodological distinction, not a claim about how this trial analyzed healing.

What is the role of the posted planning illustrations?

The sample-size illustrations use the observed effect as a planning reference and show hypothetical group sizes for stated fractions of that effect. They are not a reconstruction of the original trial design. The original design assumptions, including the anticipated effect and the basis for selecting enrollment, are not reported in the registry record. The distinction matters because a calculation based on an observed estimate answers a planning question under its assumptions, not whether the original study was adequately planned or whether an effect is certain to recur.

All statistical methods require assumptions. For a mean comparison, general considerations include the suitability of the mean as a summary, the distribution of observations, independence of observations, and the method used to estimate uncertainty. The registry record does not report diagnostic checks, transformations, robust methods, or sensitivity analyses. Their use should not be inferred from the posted summaries. The results are best read as the descriptive arm summaries and comparisons recorded, with the unreported analysis details kept in view.

11. Confidence Intervals and Precision

The primary confidence interval for the mean difference is -11.1 to -8.302 minutes. Its position entirely below zero indicates that the reported estimates within the interval favor a lower mean duration in the Gomco group under the stated comparison direction. The interval also gives a sense of precision: it spans a finite range of plausible estimates rather than providing a single exact value. It does not imply that each participant's duration falls within that range, because the interval concerns the group difference, not individual outcomes.

The registry does not report the confidence level or all details of the interval calculation. General interpretation of a confidence interval depends on its construction and assumptions. It is not correct to treat the interval as a probability distribution for the true difference or to infer that values outside it are impossible.

For pain, the interval for the mean difference is -1.187 to -0.213 units on the 10 point pain scale. It also remains below zero, but it pertains to a secondary outcome and should be interpreted in the context of multiple outcomes and the absence of reported multiplicity procedures. The registry does not report adjusted intervals or a prespecified hierarchy for secondary outcomes.

Precision is distinct from practical importance. An interval can be informative about the direction and uncertainty of an estimate without establishing whether the magnitude matters in a particular setting. The record does not provide a threshold for a clinically or operationally important difference in duration, nor such a threshold for pain. The posted estimates therefore describe the observed comparisons; judgments about importance require context not reported in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants and not total events. The registry's planning assumptions specify a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. Those assumptions describe the posted planning illustrations; the original trial's own design assumptions are not reported in the registry record.

The rows represent planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The columns describe participants per arm for 80% power and participants per arm for 90% power. In plain language, power is the chance that a planned study would detect an effect of the specified size using the stated statistical assumptions, if that effect and the assumptions were correct. The higher power target requires more participants per arm for a given effect size.

The figures are illustrations, not a claim about what the completed trial achieved. Smaller effects require more participants to distinguish them from random variation with the same target power and significance level. The observed effect used as a planning reference is estimated from this trial and can itself be uncertain; planning around it does not guarantee the same effect in a future study.

This is not observed power. It is a forward-looking calculation under stated assumptions, not a retrospective measure of the trial's success. The registry does not report the original sample-size justification, any assumptions used when the trial was designed, or whether enrollment was changed during the study. The planning figures should therefore be read only as conditional illustrations based on the observed effect and listed calculation assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -9.700; pooled standard deviation σ = 5.042.
2. n = 2 × (1.96 + 0.842)² × 5.042² / -9.700² = 4.2, rounded up to 5 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -9.7                      # observed difference in means
sigma <- 5.04232089419148                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1688310)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 5 (80% power), 6 (90% power)
 75% of observed effect: n per arm = 8 (80% power), 11 (90% power)
 50% of observed effect: n per arm = 17 (80% power), 23 (90% power)
power.t.test: 5.4 
Simulated power at n = 5 per arm: 0.763 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study examines multiple outcomes, comparisons, time points, or analyses. Even when each statistical test is conducted correctly, considering many tests can increase the likelihood that at least one result appears statistically notable by chance. General approaches include specifying a primary outcome, setting a hierarchy for secondary outcomes, or adjusting inference for multiple comparisons. The registry identifies intraoperative duration as primary and lists multiple secondary outcomes, but multiplicity procedures are not reported in the registry record.

The posted pain result includes an unadjusted p-value. Without a reported testing plan, it is not possible to determine whether that value was intended as confirmatory, exploratory, or one element of a larger family of comparisons. No adjusted p-values or multiplicity-adjusted confidence intervals are reported. The primary result is distinct because it is identified as the primary outcome, but the registry does not provide enough detail to establish the full prespecified analysis plan.

Missing-data handling is also important. A group mean and standard deviation do not by themselves show whether every randomized participant contributed an outcome measurement. The primary population is labeled all participants, and the posted arm summaries report 100.0 per arm; however, the record does not describe missing observations, exclusions, imputation, or whether the analysis followed intention-to-treat principles. It is therefore not possible to establish from the registry record how missing primary or secondary measurements were handled.

The record does not report a detailed analysis population for each endpoint, protocol deviations, or sensitivity analyses. It also does not give reasons for any unavailable outcome data. These omissions limit assessment of whether the reported comparisons could be affected by differential missingness or analytic choices. No particular problem should be inferred, but the absence of reporting prevents a full audit of these issues.

Interim analyses and stopping rules are not reported in the registry record. Nor are subgroup analyses, covariate adjustments, or a statistical analysis plan. These details matter because decisions made during data collection or analysis can affect how results should be interpreted. Without such information, the most transparent approach is to distinguish the posted primary comparison from the unadjusted secondary comparison, and not assume procedures that the record does not describe.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: serious post-operative complication (0.0%).

The registry reports zero serious adverse events affecting participants in each arm. The serious adverse event term listed is Serious post-operative complication, with a reported value of 0.0%. For other adverse events, the record reports 7 affected participants in the open surgical arm and 18 in the Gomco clamp with tissue adhesive arm. The number at risk is recorded as 100 in each arm for both serious and other adverse events.

These figures are counts of participants reported as affected, not a description of every event or its severity. The registry record does not report event-level details, definitions for other adverse events, or a statistical comparison of the counts. Death counts are not reported in the registry record.

Zero recorded serious events should not be interpreted as proof that serious complications cannot occur. It describes what was recorded in this trial under the registry's reporting. Similarly, the other adverse-event counts alone do not establish a causal explanation or a comprehensive comparative safety conclusion. Interpretation is limited by the lack of detail on event type, timing, assessment, and completeness of reporting.

16. What the Result Does, and Does Not, Mean

The primary result describes a lower average intraoperative duration in the Gomco clamp with tissue adhesive arm than in the open surgical arm. The reported mean difference is -9.7 minutes, and its confidence interval remains below zero. This is a comparison of group averages for the specified duration measure; it does not mean that every Gomco procedure took less time than every open surgical procedure.

The result does not establish that one technique is preferable in every respect. The primary endpoint measures time from the first manipulation of tissue under local anesthesia to dressing. It does not directly measure healing, cost, patient satisfaction, cosmetic result, or the difficulty of learning the procedure. Numerical registry results for most of those named secondary outcomes are not reported in the registry record.

The randomized design supports interpreting the reported difference as a comparison between assigned groups, but details about allocation implementation, missing data, and analysis populations are not reported. The results also come from the particular trial and setting described by the registry. The record does not establish how well the findings apply to other clinicians, facilities, populations, or practice conditions.

The pain result is a secondary comparison and should be interpreted with more caution because it is unadjusted and the multiplicity plan is not reported. The adverse-event figures likewise provide counts, not a complete account of event types or a formal safety comparison. Neither result should be converted into broad conclusions about overall patient experience or safety without additional information.

Finally, statistical evidence and practical importance are different questions. The posted confidence interval and p-value characterize the primary comparison under the analysis used, but the registry does not state a threshold for an important change in procedure time. The data describe an observed difference and its reported precision; they do not alone determine its operational significance or resolve outcomes that are not numerically reported.

17. Why This Trial Matters Statistically

This trial illustrates how a clinical question can be translated into a measurable continuous outcome. The endpoint has a concrete time-based definition, and the comparison is expressed in minutes, the same units used for measurement. Reporting arm means, standard deviations, a mean difference, and a confidence interval makes it possible to consider both the direction of the result and the spread and uncertainty around it.

It also illustrates why statistical significance is not a complete interpretation. The unadjusted primary p-value is small, but a p-value alone does not describe the magnitude of the contrast, its precision, or its practical importance. The mean difference and confidence interval supply complementary information. Readers still need contextual criteria to judge whether the observed duration difference matters for the settings in which the procedure is performed; such a threshold is not reported in the registry record.

The registry identifies several secondary outcomes that are conceptually distinct from duration. This highlights an important statistical distinction: a primary outcome can organize the main comparison, while additional outcomes provide other perspectives but raise questions about multiplicity and selective availability of results. Since numerical results are not reported for most named secondary outcomes, the record supports only a limited account of the trial's broader outcome profile.

The sample-size illustrations also offer a useful lesson in planning. They relate hypothetical group sizes to fractions of the observed effect under explicit assumptions, rather than documenting the original rationale. Keeping that distinction clear prevents a retrospective planning calculation from being mistaken for evidence about the study's original design or its achieved power.

18. 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.

The registry record leaves important details unavailable for evaluating the comparison fully. It does not report the randomization sequence method, allocation concealment, baseline characteristics, or the statistical analysis plan. It does not report whether the primary analysis adjusted for covariates or how protocol deviations were handled. These omissions limit assessment of the implementation and analysis, but do not establish that a particular design flaw occurred.

The primary outcome is labeled with a timeframe of 1 year, while its definition describes time during the procedure. The record does not explain this pairing. The primary population is listed as all participants, but missing-data procedures and the exact analysis population are not reported. It is not possible to determine from the record whether all randomized participants contributed complete primary outcome data.

Most named secondary outcomes do not have numerical results in the registry record. Multiplicity procedures, outcome prioritization beyond the primary designation, and interim analyses are also not reported. This makes it difficult to assess the completeness and confirmatory status of secondary findings. The numerical pain result is unadjusted.

For adverse events, the record gives counts but does not provide detailed event descriptions, definitions, severity information for other events, or a comparative statistical analysis. The death counts are not reported in the registry record. Zero serious events in the posted data should therefore be understood as a recorded trial finding, not as evidence that serious events are impossible or that all safety questions have been resolved.

Finally, the registry does not state a threshold for an important difference in duration or pain, and it does not provide detail sufficient to assess generalizability beyond the described context. The reported results are useful as a trial comparison, but conclusions about operational importance, other outcomes, and applicability require information not reported in the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision — NCT01688310.
• Registry record last updated 2013-09-10; status last verified 2013-06.
• Results first posted 2013-09-10.
• 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.

22. Record Summary

The registry record describes a completed randomized parallel trial comparing open surgical circumcision with Gomco clamp circumcision followed by tissue adhesive. It lists 200 participants enrolled, with masking recorded as none. The primary outcome is intraoperative duration in minutes, defined from the first manipulation of tissue under local anesthesia to dressing.

The posted primary comparison reports means of 22.5 minutes for open surgery and 12.8 minutes for Gomco, with a mean difference of -9.7 minutes and a confidence interval from -11.1 to -8.302. The unadjusted p-value is < 0.001. A secondary pain comparison is also reported; numerical results for most other named secondary outcomes are not reported in the registry record.

Interpretation is limited by unreported design and analysis details, including the original sample-size rationale, missing-data procedures, and multiplicity methods. Serious adverse events affecting participants are recorded as zero in each arm; other adverse-event counts are reported without event-level detail.