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 Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery (NCT02125838), a randomized na study. The primary outcome is Asses to Ventilation Parameters.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02125838 |
| Phase | NA |
| Condition | Anaesthesia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 108 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dokuz Eylul University |
| Results posted | Yes |
2. Clinical Question
Population
Women undergoing laparoscopic gynecologic surgery. The registry record does not report further eligibility details or a more specific description of the analyzed population.
Intervention
A laryngeal mask airway-Supreme, identified in the record as the LMS group. The stated comparison was made without neuromuscular agents and with positive pressure ventilation.
Comparator
An endotracheal tube, identified as the ETT group. The trial description likewise frames this comparison as taking place without neuromuscular agents.
Primary question
How do tidal-volume measurements during the intraoperative period compare between the LMS and ETT groups at the specified measurement times? The record describes this question but does not report the group means, standard deviations, or a comparative estimate.
The trial’s stated aim was to compare the airway devices during laparoscopic gynecologic intervention from a surgical perspective and in terms of their effects on ventilation parameters. Its primary outcome description focuses on tidal volume, measured at specified points in the operation. The record also identifies airway morbidity and other procedural or physiological measures as secondary outcomes, including postoperative sore throat, gastric distention, the surgeon’s view, orogastric tube placement, and hemodynamic response to device insertion.
This is a comparison of devices in a defined surgical setting, not a general comparison across all procedures or patient populations. The registry record does not establish whether the devices differed on the primary outcome, how large any difference was, or how precisely it was estimated. Those questions require numerical outcome results and an analysis, neither of which is reported in the registry record.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group trial of the laryngeal mask airway-Supreme and an endotracheal tube for laparoscopic gynecologic surgery. The record lists 108 as the enrollment and marks the study as completed. Its phase is listed as NA. The sponsor is Dokuz Eylul University.
The study start is recorded as 2013-05, and primary completion is recorded as 2015-03. These dates describe the registry timeline; they do not, on their own, explain when recruitment began or ended, how long participants were followed, or when results were analyzed. Such details are not reported in the registry record.
The intervention descriptions identify the two airway devices. For the LMS group, the record gives device sizes according to weight categories. For the ETT group, it describes a tube-size range for women. The stated aim frames the comparison as taking place without neuromuscular agents and with positive pressure ventilation. The registry record does not provide enough detail to reconstruct the full clinical protocol, including the precise procedures used to insert and manage each device.
Random allocation is intended to make treatment groups comparable on average, while masking can reduce some influences of treatment knowledge on care or assessment. The record labels the trial randomized and double-masked, but does not specify who was masked, how allocation was generated or concealed, or how masking was maintained. Those methods are not reported in the registry record.
The registry lists eight outcome measures, including the primary ventilation outcome and secondary measures related to surgical view, gastric distention, tube placement, hemodynamic response, and postoperative sore throat. It does not report an analysis record for these outcomes. Consequently, the design information identifies the intended comparison and outcome areas, but does not show the trial’s numerical findings or explain how the analyses were carried out.
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.
Overall Study
| Stage | Group ETT | Group LMS |
|---|---|---|
| STARTED | 54 | 54 |
| COMPLETED | 50 | 50 |
| NOT COMPLETED | 4 | 4 |
Reasons for not completing this period:
| Reason | Group ETT | Group LMS |
|---|---|---|
| Lost to Follow-up | 4 | 4 |
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 | Group ETT | Group LMS | Total |
|---|---|---|---|---|
| Participants analysed | 54 | 54 | 108 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 54 | 54 | 108 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 54 | 54 | 108 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: Turkey | participants | 54 | 54 | 108 |
6. Primary Endpoint
The registry lists the primary outcome as Asses to Ventilation Parameters, measured over intraoperative period.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ml |
| Endpoint classification | Continuous Endpoint |
The primary outcome is described as tidal volume, measured in milliliters and summarized as a mean with a standard deviation. Measurements were planned during the intraoperative period at T1, 2 minutes after airway-device insertion; T2, 10 minutes after insufflation; T3, before desufflation; and T4, before removal of the airway device.
Tidal volume is the amount of gas delivered with a breath during ventilation. In this trial, repeated measurements at different operative moments were intended to describe ventilation while the surgical conditions changed. Comparing the groups at these time points could show whether the recorded tidal volumes followed different patterns during the procedure. This is a general explanation of what the measure can convey; it does not establish that any difference occurred in this trial.
The registry’s endpoint description does not report numerical means, standard deviations, between-group estimates, confidence intervals, or significance tests at any measurement time. It also does not state a single prespecified time point as the sole primary comparison. The record explicitly indicates that the primary outcome has several time points and is not reduced to one comparison. Without the outcome values and analysis, the endpoint cannot be used to assess the size, direction, or precision of a difference between the airway-device groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies an intended comparison of tidal-volume measurements between an LMS group and an ETT group during laparoscopic gynecologic surgery. It does not report the group means or standard deviations at T1, T2, T3, or T4. Nor does it report a comparative effect estimate, confidence interval, or p-value for these measurements. The result of the primary comparison is therefore not reported in the registry record.
This absence is important for interpretation. A study objective and an outcome definition describe what investigators intended to measure; they are not evidence of the observed result. The trial’s background text presents reasons for considering a laryngeal mask, but those statements do not substitute for the trial’s own outcome data. No conclusion about the relative tidal volumes in the two groups can be drawn from the registered objective alone.
The enrollment is recorded as 108, while the adverse-event entries separately identify 50 participants at risk in each group. These are different registry fields with different purposes. The adverse-event risk counts should not be treated as the analyzed sample size for the primary outcome, and the record does not explain how the enrollment figure relates to those safety populations. The number analyzed for tidal volume, and the reasons any participants may have been excluded from an analysis, are not reported in the registry record.
The registry also lists secondary outcomes, but provides no numerical results for them in the record described. Their presence in the outcome list does not indicate whether they were measured successfully, what their findings were, or how they were analyzed. Likewise, zero analysis records means the registry does not present an analysis entry for interpreting the stated outcomes; it does not tell readers what unreported analyses may have been conducted elsewhere.
In general, a confidence interval communicates the range of effect sizes compatible with an estimate under the assumptions of the analysis. Without an estimate and interval, the precision of the comparison cannot be judged. A p-value, if one were reported, would address compatibility with a specified null model rather than establish the size or practical importance of a difference. No p-value is reported for the primary outcome, so none can be interpreted.
The appropriate reading is limited: the record documents a randomized, double-masked, parallel-group comparison and defines a repeated-measure ventilation outcome. It does not provide the numerical findings needed to say whether the groups differed, by how much, or with what precision. The record also does not report enough statistical detail to assess whether the intended analysis accounted for measurements repeated within participants or for the several assessment times.
9. Statistical Methods Explained
The registry supplies design labels and an outcome definition, but it does not report the statistical methods used to analyze the trial outcomes. The explanations below are general statistical context, not a description of analyses confirmed in the registry record.
What does a mean and standard deviation describe?
A mean summarizes the average value in a group. A standard deviation describes how spread out individual measurements are around that group average. Reporting both can help readers understand the typical measurement and the variability among observations. For this trial, the primary outcome is specified as a mean and standard deviation, but the actual values are not reported in the registry record. The group summaries therefore cannot be compared or interpreted from this record.
Why do the measurement times matter?
Tidal volume is described at T1, T2, T3, and T4, with each time tied to a different point in the procedure. Measurements from the same participant are generally related: a person’s value at one time may be associated with that person’s value at another time. As a general statistical principle, an analysis of repeated measurements can account for this within-participant relationship. Treating all observations as independent when they are related can misstate uncertainty. The registry record does not identify whether the investigators used a repeated-measures model, separate comparisons at each time, or another approach.
The endpoint description names several time points and states that it was not reduced to one comparison. When several comparisons are made, the chance of at least one apparently unusual result can increase if the analyses are interpreted without regard to multiplicity. General approaches include defining a primary contrast in advance, adjusting for multiple comparisons, or interpreting the set of results with suitable caution. The registry does not report which approach, if any, was planned or used. No adjustment can be inferred from the outcome description.
What would an effect estimate and interval add?
A between-group estimate would describe the observed contrast in tidal volume, with its direction and magnitude expressed in the relevant units. A confidence interval would communicate uncertainty around that estimate. In general, a narrow interval indicates greater precision than a wide interval, while an interval spanning effects in different directions may leave the direction uncertain. Neither the estimate nor an interval is reported for the primary outcome. The record therefore does not permit evaluation of effect size or precision.
A significance test, if used, would evaluate the observed data against a specified statistical model and null hypothesis. Its interpretation depends on the analysis choices and assumptions. A p-value is not a measure of the probability that a treatment is effective, nor does it describe the size of an effect. The registry record does not report a p-value or the statistical test for the primary outcome. No significance conclusion can be reconstructed from the endpoint description alone.
What assumptions can be assessed from the record?
The endpoint is continuous and is to be summarized using a mean and standard deviation. General methods for continuous outcomes may rely on assumptions about the distribution of measurements or model errors. Repeated-measures methods also require an appropriate treatment of within-participant dependence. The registry does not report diagnostic checks, transformations, model specifications, or alternative analyses, so these assumptions cannot be evaluated for this trial.
Randomization can support a fair comparison by balancing known and unknown participant characteristics on average, but it does not guarantee that every measured or unmeasured feature is balanced in the realized groups. The record does not report baseline characteristics or details of sequence generation and concealment. Double masking can limit some forms of bias, but the registry does not identify which people were masked or whether masking was successful. These design labels should therefore be read as registry descriptions, not as complete evidence about implementation.
What do the planning assumptions mean?
The registry includes a description of sample-size planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect, and that non-time-to-event planning values are expressed as participants per arm. These are described as planning illustrations, not as the trial’s original design rationale or observed power.
The registry does not report the values for those illustrations in the record described, and it does not report the observed effect needed to interpret them. They cannot be used to infer the trial’s actual power, whether the trial met a prespecified target, or how the original enrollment was justified. The sample-size justification and the statistical plan are not reported in the registry record.
Overall, the registry gives enough information to identify the outcome type and measurement schedule, but not enough to reproduce or assess an analysis. The actual model, handling of missing observations, multiplicity strategy, analysis population, and numerical results are not reported in the registry record. General statistical principles can clarify what those details would mean, but they cannot fill in the missing trial-specific information.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is measured at several intraoperative time points. A set of time-specific comparisons creates a multiplicity issue: when many hypotheses are assessed, interpreting each result as if it were the only test can increase the chance of a false-positive finding. General strategies include prespecifying a primary time point or contrast, controlling the overall error rate, or treating the full set of comparisons as exploratory. The registry record does not report a multiplicity plan or identify one time point as the sole primary comparison.
The record lists eight outcome measures, including the ventilation outcome and secondary measures. It does not report how many statistical tests were conducted, which outcomes were analyzed, or whether any adjustment was applied. It would be inappropriate to assume either that multiplicity was controlled or that every listed outcome was formally tested.
Missing-data handling is also not reported. The record does not state whether measurements were missing, how missing observations were handled, or whether any sensitivity analyses were performed. The number of participants included in the primary analysis and the analysis population definition are not reported in the registry record. The enrollment figure alone does not establish the number contributing data at every time point.
These omissions limit evaluation of bias and precision. Missing observations can affect estimates if the chance of missingness is related to participant characteristics or outcomes. General methods may rely on assumptions about why data are missing; those assumptions cannot be checked without trial-specific information. The registry does not report the statistical plan, interim analyses, or a sample-size justification. Accordingly, the available record supports describing the intended design and outcome schedule, but not determining whether the analyses followed a prespecified plan or how robust any results would be.
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 |
|---|---|---|---|
| Group ETT | 0 | 50 | 0.0% |
| Group LMS | 0 | 50 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group ETT | 0 of 50 |
| Group LMS | 0 of 50 |
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 |
|---|---|
| Group ETT | 0 of 50 |
| Group LMS | 0 of 50 |
The adverse-event record reports, for Group ETT, 50 at risk for serious adverse events and zero affected, as well as 50 at risk for other adverse events and zero affected. For Group LMS, it reports 50 at risk for serious adverse events and zero affected, as well as 50 at risk for other adverse events and zero affected. Deaths are recorded as zero in each group. No top serious-event terms are listed.
These entries describe what is recorded in the registry, not proof that no event occurred or that the devices have equivalent safety. A zero count can reflect no recorded events in the specified registry fields, but the record does not provide details about event definitions, collection methods, follow-up completeness, or adjudication. The reported at-risk populations also do not establish how many participants contributed to the primary outcome analysis.
Because the registry does not report further safety methods or event-level details, the figures should be interpreted narrowly as the posted adverse-event counts. They do not quantify rare risks or establish comparative safety. The record does not report a statistical comparison of adverse events between groups.
12. What the Result Does, and Does Not, Mean
The trial record documents a randomized, double-masked, parallel-group comparison of a laryngeal mask airway-Supreme and an endotracheal tube during laparoscopic gynecologic surgery. It specifies tidal volume as the primary outcome and describes when measurements were to be taken. It also records a set of secondary outcomes and adverse-event counts.
What the record does not establish is whether the airway devices produced different tidal-volume measurements. There are no numerical primary outcome results, group summaries, effect estimates, confidence intervals, or p-values reported. The direction, magnitude, and precision of any difference are therefore unknown from the registry record. The same limitation applies to the secondary outcomes: their names are recorded, but their numerical findings are not reported.
The record’s background text describes arguments for considering laryngeal masks and summarizes claims about prior experience. Those statements are not trial results. The trial objective likewise does not show that either device performed better. A study can be designed to answer a question without the registry record containing the information needed to answer it.
The safety entries show zero serious events, zero other adverse events, and zero deaths recorded for the listed groups, with 50 at risk for each event category in each group. These figures should not be taken as proof of no risk or as evidence of equivalence. The registry does not provide event definitions, detailed follow-up information, or a comparative safety analysis.
In general, statistical evidence is best interpreted through an effect estimate and its uncertainty, alongside study design and outcome definitions. Those numerical results are not reported for the primary comparison. No conclusion about efficacy, clinical benefit, or absence of a difference follows from the available outcome description. The defensible interpretation is that the registry defines a relevant comparative question but does not report the findings needed to resolve it.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a registered research question and a reported result. The record identifies a randomized comparison, the devices under study, and a continuous ventilation outcome assessed at several moments during surgery. These details clarify what the investigators intended to compare, even though the numerical analysis is not reported.
The multiple assessment times matter for interpretation. Repeated observations can describe how an outcome changes over the course of an operation, but they also require a clear plan for handling related measurements and for interpreting several comparisons. Without the analysis method, a reader cannot determine how the time points were combined or whether multiplicity was addressed. This is a general issue in repeated-measure clinical studies, not evidence of a flaw in this trial.
The record also illustrates why enrollment and analysis populations should not be conflated. It records enrollment as 108 and separately gives adverse-event populations at risk of 50 in each group. The primary analysis population is not reported, and the safety counts do not supply it. Keeping these quantities tied to their stated purposes prevents unsupported conclusions about the amount of outcome data available.
Finally, the listed safety counts are not a substitute for the primary outcome results or for detailed safety reporting. Zero recorded events may be relevant to the registry’s adverse-event fields, but do not establish equivalence or rule out risk. The key statistical lesson is that design labels and outcome definitions describe the framework of a study; estimates, uncertainty, and analysis details are needed to assess what its data show.
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.
The main limitation for interpreting this trial from the registry record is the absence of numerical results for the primary outcome. No tidal-volume means, standard deviations, between-group estimates, confidence intervals, or p-values are reported for any of the specified measurement times. As a result, the primary comparison cannot be evaluated for direction, size, or precision.
The record does not explain how the several time points were analyzed, whether measurements were modeled as repeated observations, or whether a particular time point or contrast was designated as primary for inference. It also does not describe adjustment for multiple comparisons. These omissions prevent assessment of the analysis choices that would matter when interpreting several related outcomes.
Information about the analysis population and missing observations is not reported. The registry does not state how many participants contributed tidal-volume data at each measurement time or how missing measurements were handled. Enrollment and adverse-event risk counts cannot be used to infer those quantities.
Although the study is labeled randomized and double-masked, details of sequence generation, allocation concealment, masking roles, and masking success are not reported. The record also does not report baseline characteristics, protocol deviations, or the statistical analysis plan. The sample-size justification and interim analyses are not reported in the registry record.
The safety entries list zero affected for the specified event categories, but do not provide event definitions, detailed ascertainment methods, follow-up completeness, or a statistical comparison. These limits make the adverse-event figures unsuitable as proof of equivalent safety. Taken together, the registry record identifies the trial’s purpose and framework but leaves important results and methods unavailable for independent statistical assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery — NCT02125838.
- Registry record last updated 2017-03-28; status last verified 2017-02.
- Results first posted 2017-03-28.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes NCT02125838, “Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery,” as a completed, randomized, double-masked, parallel-group study sponsored by Dokuz Eylul University. Enrollment is recorded as 108. The study start is 2013-05, and primary completion is 2015-03.
The comparison is between a laryngeal mask airway-Supreme and an endotracheal tube in laparoscopic gynecologic surgery. The primary outcome is mean tidal volume in milliliters with standard deviation, assessed at T1, T2, T3, and T4 during the intraoperative period. The record also lists secondary surgical, procedural, hemodynamic, and postoperative outcomes.
Numerical primary and secondary outcome results, analysis methods, and the analysis population are not reported in the registry record. Adverse-event entries list zero serious events, zero other events, and zero deaths for both groups, with 50 at risk in each group for the event categories.