Global Sinus Surgery Registry: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Global Sinus Surgery Registry (NCT02347943), a registered phase not stated study. The primary outcome is Number of Participants Completing Follow-Up Visits.

2. Clinical Question

The study’s stated aim was to evaluate long-term safety and effectiveness of primary sinus surgery in a real-world adult population with CRS or RARS. That aim is broader than the available results: the registry record contains adverse-event entries for the listed groups, but no reported analyses, effect estimates, or primary endpoint results. The clinical question therefore remains an intended question rather than one answered by the posted endpoint data. The group labels describe procedures recorded in the registry; they do not, by themselves, establish that the groups were assigned under comparable conditions or that differences between them would be attributable to procedure choice.

3. Trial Design

The Global Sinus Surgery Registry, also named the OASIS Global Sinus Surgery Registry, was sponsored by Integra LifeSciences Corporation. The record lists a study start of 2015-01-01 and a primary completion date of 2015-11-01. Its status is TERMINATED. The registry describes the study as a post-market evaluation in a real-world population of adults with CRS or RARS undergoing primary sinus surgery with commercially available sinus instrumentation.

The listed procedural groups are Balloon Sinus Dilation (BSD), Endoscopic Sinus Surgery (ESS), and Hybrid. The record classifies the study as kind “other” and does not state allocation. It is not a randomized comparison; the registry cautions that the arms are not a like-for-like control comparison. Accordingly, the group labels should be read as categories in the registry, not as evidence of randomized assignment or equivalent baseline characteristics. The record does not report a protocol-level explanation of how treatment decisions or group membership were determined.

The planned primary outcome was the number of participants completing follow-up visits at 2 years. However, the registry states that this endpoint’s data were not collected because of early cancellation. It lists one outcome measure and zero analyses. Thus, the planned follow-up question has no posted result, and the record does not supply an efficacy comparison or a statistical assessment of follow-up completion.

Enrollment is listed as 252. This is a registry enrollment figure, not a count that can be assigned to the groups based on the entries shown. The group-specific at-risk figures are reported separately in the adverse-event information. The record does not report a sample-size justification, an interim-analysis plan, or a detailed statistical analysis plan. The dates, terminated status, and missing endpoint data describe the registry record, but do not by themselves explain why the study ended early or what analyses may have been intended.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Due to early cancellation of the study data for this endpoint were not collected.

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 Number of Participants Completing Follow-Up Visits, measured over 2 years.

The primary endpoint is titled “Number of Participants Completing Follow-Up Visits,” with a timeframe of 2 years. It is intended to describe whether participants continued through the scheduled follow-up period. In general, follow-up completion is useful because it indicates how much planned observation was obtained. When follow-up is incomplete, safety and effectiveness outcomes may be harder to interpret: events may go unrecorded, and the participants with available observations may differ from those without them.

For this registry, the endpoint does not have a reported result. Its population description states that data were not collected due to early cancellation of the study. The record therefore gives no count of participants completing visits, no group-specific completion information, and no estimate of uncertainty around completion. No comparison can be made from this endpoint between BSD, ESS, and Hybrid.

The stated timeframe does not imply that follow-up was completed or that the endpoint was observed. A planned measure and a measured result are different things. The cancellation note is especially important: the absence of endpoint data is not evidence that no participants completed follow-up, and it is not a reported zero. It means the registry record contains no collected data for this primary outcome. The record also does not explain whether any partial follow-up information existed outside this endpoint entry.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record contains descriptions of the intended study and selected adverse-event entries, but no statistical analyses are reported. The methods below explain how such information is ordinarily interpreted; they do not describe an analysis documented for this registry. The primary endpoint data were not collected, so statistical methods cannot recover a result that is absent from the record.

What does a descriptive count say?

A count reports how many entries or affected participants the registry records for a category. The adverse-event fields list affected counts alongside the corresponding at-risk figures. These entries can describe what was recorded in each procedural group, but they do not establish why an event occurred or whether the groups had comparable chances of experiencing or reporting it. A descriptive count is not, by itself, an estimate of a causal treatment effect.

It is also important to preserve the registry’s distinction between the serious adverse-event field and the other adverse-event field. The record lists counts in both. It does not provide additional detail in the posted entries about event timing, repeat events, adjudication, or the operational definitions used. Therefore, interpretation should stay close to the reported categories rather than assume details that are not stated.

Why does allocation matter?

Random allocation, when used and properly implemented, can help make comparison groups similar with respect to measured and unmeasured characteristics at the start of a study. The registry does not report randomization and explicitly cautions that the arms are not a like-for-like control comparison. Allocation is not stated. A numerical difference between groups in a non-randomized registry can arise from differences in patient characteristics, clinical decisions, follow-up, or recording, in addition to any association with the procedure.

In general, statistical adjustment can sometimes address measured differences, but it cannot automatically remove bias from unmeasured factors or inadequately recorded information. No adjusted analyses are reported for this registry. The group-specific entries should therefore be understood descriptively, without interpreting them as a fair head-to-head comparison.

What would an estimate and its uncertainty contribute?

In general, an estimate summarizes the size of an observed quantity, while a confidence interval gives a range of values reasonably compatible with the data under the method’s assumptions. A narrower interval generally indicates greater precision, and a wider interval indicates more uncertainty. A p-value, when reported, describes how compatible data are with a specified null hypothesis under a statistical model; it does not measure clinical importance or prove that a result is true.

The registry record reports no confidence intervals, p-values, or effect estimates for the primary endpoint. That is consistent with the statement that endpoint data were not collected and with the listing of zero analyses. It is not possible to judge precision or statistical significance for the primary question from the record.

How should the planning illustration be read?

The registry’s planning-illustration description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the target effect as a stated fraction of an observed effect. For time-to-event calculations, it says the illustration uses the total number of events; other calculations use participants per arm. These are assumptions for a planning illustration, not a reported analysis plan for the terminated study.

The record does not provide an observed effect estimate for the primary endpoint, because its data were not collected, or numerical planning outputs in the registry record described for this record. Consequently, no particular planning size or detectable effect can be interpreted from these details. Any sample-size illustration is a planning exercise, never observed power. The record does not report the study’s own sample-size justification, so the planning assumptions should not be mistaken for the rationale used to enroll participants.

What does early cancellation change?

When an endpoint is not collected, the issue is not simply reduced precision around an observed estimate. There is no endpoint estimate to analyze. General methods for handling missing observations require information about which observations are missing, why they are missing, and what variables are available. The registry does not report such detail for the primary endpoint; it states that data were not collected because of early cancellation. No imputation or sensitivity analysis is reported.

Thus, the strongest methodologically grounded conclusion is about the record itself: it documents the planned endpoint and the reason given for its lack of data, but it does not support an endpoint estimate or comparison. General statistical concepts can explain what would be needed for interpretation, but they cannot supply results that the registry does not report.

10. Multiplicity, Missing Data and Analysis Populations

The registry record does not report a multiplicity plan. Multiplicity concerns arise when several outcomes, comparisons, time points, or analyses are tested: the more opportunities there are to find a nominally unusual result, the more important it is to specify in advance which analyses are primary and how multiple testing will be handled. Here, the record identifies one primary outcome measure, but the absence of reported analyses means there are no posted tests to evaluate for multiplicity. The record does not describe additional planned outcomes or a hierarchy of outcomes.

Missing data are central to the primary endpoint. The registry says that data for the number of participants completing follow-up visits at 2 years were not collected due to early cancellation. It does not report participant-level missingness, partial follow-up, reasons for individual departures, or methods for imputing missing observations. Because the endpoint data were not collected, there is no reported estimate to adjust or test through a missing-data model. The record does not report sensitivity analyses that explore alternative assumptions about missing outcomes.

Analysis populations are not reported in the registry record. It does not identify an intention-to-treat, per-protocol, or safety analysis population, nor does it describe exclusions from analyses. These labels have specific meanings in clinical research, but none should be assigned to this study based on the available record. The group-specific at-risk figures in the adverse-event entries do not establish an analysis population for the primary endpoint.

The registry also does not report interim analyses or monitoring procedures. Their presence or absence in the study’s conduct cannot be inferred from the missing endpoint result. Overall, missing endpoint data, absent analysis-population definitions, and no posted analysis plan limit the ability to assess bias and statistical validity. These are reporting gaps in the registry record, not grounds to infer a particular unreported method.

11. 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 0.1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: acute pulmonary oedema (1.5%), pneumonia (0.7%).

The adverse-event information is descriptive. For BSD, the registry lists 1 affected in the serious adverse-event field among 140 at risk, and 8 affected in the other adverse-event field among 140 at risk. For ESS, it lists 1 in the serious field among 67 at risk and 4 in the other field among 67 at risk. For Hybrid, it lists 0 in each field among 45 at risk. These entries should be read as recorded group-specific counts, not as adjusted risks or evidence of a difference between procedures.

The registry’s “top serious terms” are acute pulmonary oedema at 1.5% and pneumonia at 0.7%. The entries do not report the denominator or group attribution for these term percentages. The deaths fields are not reported in the registry record; that should not be interpreted as a reported count of zero deaths.

In general, adverse-event comparisons require consistent definitions, ascertainment, follow-up, and appropriate handling of differences between groups. The registry does not provide enough information in these entries to assess those features. Its explicit warning that the arms are not a like-for-like comparison is especially relevant to safety interpretation. The counts can be reported as recorded, but they do not establish that one procedure has greater or lesser safety than another.

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

The record establishes that the OASIS Global Sinus Surgery Registry was intended to evaluate long-term safety and effectiveness of primary sinus surgery in a real-world adult population with CRS or RARS. It names three procedural groups and reports selected adverse-event information. It also makes clear that the study was terminated and that data for the primary follow-up endpoint were not collected because of early cancellation.

What the record does not establish is whether participants completed follow-up at 2 years, whether completion differed among the groups, or whether the procedures differed in effectiveness. There is no reported primary endpoint estimate, no confidence interval, and no statistical analysis. The adverse-event counts and serious terms are descriptive entries and do not provide a like-for-like comparison. The record does not state allocation, and it cautions that the arms are not comparable as control groups.

In general, a registry’s intended aims should be distinguished from its observed results. Listing an effectiveness objective does not mean that effectiveness was demonstrated or disproved. Likewise, the absence of collected endpoint data is not a finding of no effect, and a recorded count of zero in an adverse-event field is not evidence that no events could occur outside the recorded information or observation period.

The most defensible interpretation is that the posted record is incomplete for the primary clinical question. It offers limited descriptive safety information, but not the comparative analyses needed to attribute differences to a procedure. It cannot quantify the precision of any treatment effect or resolve whether observed group variation reflects procedure, patient selection, follow-up, or recording. Readers should treat the missing primary outcome as unavailable evidence, not as a negative result.

13. Why This Trial Matters Statistically

This registry is statistically important as an example of the difference between a study’s intended question and the evidence available to answer it. The stated objective concerns long-term safety and effectiveness, but the primary endpoint data were not collected after early cancellation. The record reports zero analyses. As a result, there is no endpoint estimate whose size, uncertainty, or clinical relevance can be assessed.

The study also illustrates why the design and allocation structure matter when interpreting group-specific numbers. BSD, ESS, and Hybrid are listed, but allocation is not stated, the study is not a randomized comparison, and the record cautions that the groups are not like-for-like controls. Descriptive counts can be useful for documenting what the registry records, but they do not by themselves support a causal comparison.

A further lesson concerns transparency around missing outcomes. A planned follow-up measure is not interchangeable with a collected endpoint. Reporting that the endpoint data were not collected is essential context, because it prevents readers from treating the absence of a result as a zero or assuming follow-up was complete. It also clarifies why conventional measures of precision and statistical significance are unavailable for the main question.

Finally, the record shows how carefully planning illustrations must be separated from analyses of observed data. General assumptions about a significance level, allocation, and approximation do not constitute a study’s analysis plan or demonstrate statistical power. The registry does not report a sample-size justification or numerical results for the primary endpoint. Statistical interpretation depends on keeping these distinctions clear: intended design, collected data, descriptive reporting, and inferential conclusions are not the same thing.

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 most consequential limitation is that the primary endpoint data were not collected. The registry identifies early cancellation as the reason. Without the number of participants completing follow-up visits at 2 years, the main planned outcome cannot be estimated or compared across groups. The record does not describe whether any partial follow-up observations were available elsewhere.

The study is not a randomized comparison, allocation is not stated, and the registry explicitly cautions that the arms are not a like-for-like control comparison. This constrains interpretation of the adverse-event entries and would also complicate any unadjusted comparison, even if outcome data were available. No adjusted analyses are reported.

The record lists an enrollment of 252 and separate at-risk figures for adverse-event reporting, but it does not explain the relationship between enrollment, group assignment, follow-up, and analysis populations. It does not report baseline characteristics or the criteria used to place participants in the procedural groups. Such details are needed to assess comparability and potential selection effects.

Safety interpretation is also limited by the detail available in the registry entries. The top serious terms are reported with percentages, but their denominators and group attribution are not stated in those entries. Death fields are not reported in the registry record. Definitions, timing, ascertainment procedures, and treatment of repeat events are not described in the available information.

The registry does not report a sample-size justification, a detailed statistical analysis plan, multiplicity handling, interim analyses, or analysis-population definitions. These items should be treated as unreported, rather than reconstructed from general conventions. Together, the terminated status, absent primary outcome, limited design information, and descriptive safety reporting prevent a robust comparative assessment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Global Sinus Surgery Registry — NCT02347943.
• Registry record last updated 2024-07-12; status last verified 2024-07.
• Results first posted 2019-02-27.
• 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.

18. Record Summary

The Global Sinus Surgery Registry, also called the OASIS Global Sinus Surgery Registry, was sponsored by Integra LifeSciences Corporation. The record lists enrollment of 252, a start date of 2015-01-01, primary completion on 2015-11-01, and status TERMINATED. It describes a real-world post-market study of primary sinus surgery in adults with CRS or RARS using commercially available sinus instrumentation.

The listed groups are BSD, ESS, and Hybrid. The primary endpoint was the number of participants completing follow-up visits at 2 years, but its data were not collected because of early cancellation. The record lists one outcome measure and zero analyses. Adverse-event counts are reported descriptively, while allocation is not stated and the registry cautions that the arms are not like-for-like controls. The primary clinical question therefore remains unanswered by the posted endpoint data.