Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery (NCT02627794), a na phase 3 study. The primary outcome is Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer..

2. Clinical Question

3. Trial Design

The registry identifies this as a Phase 3 study and lists its status as terminated. The recorded start is 2015-12 and the primary completion is 2016-04. Enrollment is recorded as 3. The official title describes a double-blind randomized controlled study, while the design fields list single masking, allocation as NA, and a single-group model. The record does not explain these differing descriptions.

The device description says each nostril will receive one Silastic spacer and one Restora steroid-eluting spacer. This describes a within-person, nostril-level comparison, rather than a conventional comparison in which separate participant groups each receive one device. However, the registry does not state how the two devices were assigned to nostrils, whether assignment was randomized, or how outcomes from the two nostrils were to be compared. Its design metadata also flags the arms as not a like-for-like control comparison. These features make the intended comparative structure difficult to establish from the record.

Follow-up is described as lasting for the duration of postoperative standard care, with an expected average of 90 days. The primary outcome timeframe refers to that follow-up, while the primary description also mentions assessment of sinonasal mucosal inflammation at 35 days using rigid endoscopy and the Lund-Kennedy sinus mucosal endoscopic staging system. The record lists additional outcomes covering inflammation, intraocular pressure, synechiae, SNOT-22 scores, postoperative interventions, oral steroid rescue, and middle turbinate position.

The registry lists no analyses. It does not report a statistical analysis plan, details of masking procedures, device assignment procedures, or reasons for termination.

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

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.

Population: Each participant received a Restora Spacer on one nostril and a silicone spacer on the other nostril. We had 3 participants in total, but each received two spacers.

6. Primary Endpoint

The registry lists the primary outcome as Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer., measured over Participants will be followed for the duration of post op standard of care, an expected average of 90 days..

The primary endpoint is titled as the incidence of middle meatal synechiae after endoscopic sinus surgery in Silastic and Restora steroid-eluting spacer use. Its unit is participants, and its parameter is a count of participants. In general, an incidence endpoint records whether a defined event occurs during a specified follow-up period. For this endpoint, the clinical event is formation of synechiae in the middle meatus following surgery.

The registry background explains why this event is of interest: synechiae may impair sinus drainage, promote sinusitis, and limit endoscopic visualization, potentially making routine postoperative examination and debridement difficult. Spacers are used between nasal mucosal surfaces to prevent adhesions. The study’s stated aim is to examine basic device usability and confirm safety and effectiveness of the Restora mometasone furoate eluting spacer compared with Silastic.

The record does not define the specific endpoint assessment rule, such as how a synechia is identified for the primary outcome, whether the endpoint is assessed by nostril or participant, or how a participant with findings in either nostril would be classified. It also does not post event counts, an effect estimate, or uncertainty for the primary endpoint. The timeframe gives expected average follow-up of 90 days, while the endpoint description separately mentions 35-day endoscopic inflammation assessment. The registry does not clarify the timing used for the primary synechiae assessment.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a count endpoint mean?

The primary endpoint is a count of participants with middle meatal synechiae. For a binary event, each assessed participant is classified according to whether the event was observed under the outcome definition. A count is descriptive: it states how many participants met that definition in the data being reported. Interpreting the count as a rate or comparative effect also requires a clear denominator, a defined assessment time, and a description of how missing assessments are handled. The registry record does not post primary event counts or those analysis details.

The endpoint is titled as a participant-level outcome, but the device description assigns a spacer to each nostril. If outcome observations are collected separately for each nostril, those observations from the same participant are related rather than independent. General statistical practice accounts for this pairing when estimating uncertainty and comparing treatments. The registry does not report whether the primary endpoint was classified by participant, nostril, or another rule, and does not describe a method for handling the paired structure.

Why does the design description matter?

A statistical comparison depends on how treatment assignment and outcome measurement were organized. A parallel-group trial compares outcomes across participant groups assigned different treatments. A within-person design can compare outcomes from different body sites in the same participant, but needs the site assignment and paired analysis to be clear. Here, each nostril is described as receiving one of each spacer, but allocation is recorded as NA and the model as single group. The official title describes randomization, while the registry design note says the arms are not a like-for-like control comparison. The record does not resolve those differences.

General explanation: pairing can reduce some sources of between-person variability because observations are compared within the same person. It also means that treating paired observations as if they came from unrelated people can misstate uncertainty. This does not establish which analysis was appropriate in this study; the registry does not report its statistical method.

What would an estimate and confidence interval convey?

General explanation: an effect estimate describes the magnitude and direction of a contrast under a specified analysis. A confidence interval expresses uncertainty around that estimate; a wider interval indicates less precision, while a narrower interval indicates greater precision under the model used. Neither an estimate nor its interval can be interpreted without knowing the endpoint definition, analysis population, and comparison structure. No primary effect estimate or confidence interval is reported in the registry record.

A p-value, if reported, would address compatibility between the observed data and a specified null hypothesis under the chosen statistical model. It would not by itself show the size or practical importance of an effect. The registry lists no analyses and reports no primary-outcome p-value. No inference should be reconstructed from the enrollment or safety counts alone.

What do the sample-size assumptions describe?

The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the illustration is described as a total number of events; for other outcomes, it is described as participants per arm. These are planning assumptions, not results from the trial and not observed power.

The record does not include a reported primary effect estimate on which to assess such planning, nor does it provide the actual planning sample-size figures in the study details. It also does not report the original design’s sample-size justification or whether the planning illustration reflects the protocol. Any planning interpretation should therefore remain separate from the trial’s observed evidence. In particular, planning calculations do not substitute for a reported treatment estimate and its uncertainty.

What is missing from the analysis report?

The registry lists zero analyses. It does not report a statistical model, adjustment variables, a method for handling paired nostril observations, a confidence interval procedure, or a hypothesis test for the primary outcome. It does not describe an interim analysis or a prespecified analysis plan. These details are not reported in the registry record, so it is not possible to determine how outcomes were intended to be summarized or whether an analysis followed a prespecified plan.

General explanation: analysis choices matter because they define which observations contribute, how within-person dependence is represented, and what uncertainty accompanies an estimate. When a report lacks these details, a reader cannot reliably reconstruct the inferential analysis from endpoint labels or counts in other outcome domains. The record supports a description of the intended endpoint and selected design features, but not an independent reanalysis of efficacy.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Silastic Silicone Spacer", "Restora™ Steroid Eluting Spacer")
n      <- c(3, 3)
events <- c(3, 3)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Silastic Silicone Spacer  3  3  100.0  29.2  100.0  43.9  100.0  39.8  99.4
ARM  Restora™ Steroid Eluting Spacer  3  3  100.0  29.2  100.0  43.9  100.0  39.8  99.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and multiple secondary outcomes, including assessments of inflammation, intraocular pressure, synechiae, SNOT-22 scores, postoperative interventions, oral steroid rescue, and middle turbinate position. It does not report a multiplicity strategy, such as how interpretation would account for testing or estimating effects across several outcomes. It is also not reported whether outcome priorities or analysis choices were changed after study initiation.

General explanation: when several outcomes are analyzed, the chance of observing an apparently unusual result can depend on how many analyses are conducted and how they are selected. A prespecified hierarchy or other multiplicity approach can help clarify how findings should be interpreted. Since the registry lists no analyses and posts no outcome results, there is no basis to assess multiplicity handling in this study.

Missing-data procedures and analysis populations are not reported in the registry record. The record does not state how participants with missing endoscopic examinations or incomplete follow-up would be handled, whether all enrolled participants were included in each analysis, or how deviations from the intended device use would be treated. It also does not report an intention-to-treat, per-protocol, or safety analysis population. The terminated status makes completeness of follow-up especially important to know, but the record gives no account of completion or missingness. These omissions prevent assessment of attrition, selection into analyses, and the representativeness of any potential estimate.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry safety record lists Silastic Silicone Spacer and Restora Steroid Eluting Spacer groups. For each group, the number at risk is 3; serious adverse events are recorded as 0, other adverse events are recorded as 0, and deaths are recorded as 0. The record also lists no serious adverse event terms.

These figures describe what is entered in the registry safety fields. They should not be read as proof that no events occurred outside the reported categories or that all safety observations were complete. The record does not explain the definitions or collection procedures for serious and other adverse events, provide event-level detail, or state the period over which each safety group was observed. It also does not clarify how safety groups relate to the description that each nostril receives one of each spacer.

Zero reported events do not establish comparative safety. The record provides no analysis or uncertainty estimate for the safety outcomes, and the study is marked terminated. The counts are therefore descriptive registry entries, not a precise estimate of risk or a basis for a broader safety conclusion.

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

This record documents a study intended to assess Restora steroid-eluting and Silastic spacers after endoscopic sinus surgery, with middle meatal synechiae named as the primary outcome. It gives background on why synechiae matter in postoperative care and lists a range of additional outcomes. It also records enrollment, study dates, termination status, selected design fields, and safety counts.

It does not report the primary synechiae results or comparative analyses. There is no posted estimate of the difference between devices, no uncertainty interval, and no reported test of a primary hypothesis. The registry therefore cannot show whether the event was more or less frequent with either spacer, or how precise an estimate would be. No conclusion about effectiveness follows from the study aim, the endpoint description, or the safety counts.

The study’s comparison structure is not fully clear in the registry record. The official title describes a randomized controlled study, while the allocation and model fields do not describe a conventional randomized comparison. The device description instead says that each nostril receives one spacer of each type. Assignment procedures and the analysis of observations from the two nostrils are not reported. This limits interpretation of the intended comparison independently of the missing outcome results.

The recorded safety counts show no serious adverse events, other adverse events, or deaths in either listed safety group. Those entries are limited to the registry’s reported categories and do not resolve the absence of outcome definitions, follow-up completeness, or comparative safety analysis.

Overall, the record is informative about the question the study set out to address, but it does not provide the outcome evidence needed to answer it. The terminated status and lack of analyses further constrain what can be inferred. The appropriate reading is that comparative effectiveness and precision are not reported in the registry record, not that the devices had equivalent or different outcomes.

14. Why This Trial Matters Statistically

This study raises a statistical issue that is central to clinical device comparisons: the unit of treatment assignment and the unit of outcome measurement must be clear. The record describes one spacer of each type in each participant’s nostrils, which points toward a paired, within-person comparison. Yet the structured design fields identify a single-group model and allocation as NA, and the registry note cautions that the arms are not a like-for-like control comparison. Without an account of assignment and analysis, the contrast cannot be interpreted with confidence.

Pairing has consequences for statistical precision. General explanation: observations from two sites in the same person tend to share participant-level characteristics, so they cannot automatically be treated as independent observations. A paired method can use the relationship between the observations, but it requires a clearly defined matched outcome and a suitable analysis. The registry does not report such a method.

The record also illustrates the difference between a stated endpoint and a reported result. A well-described clinical question does not itself provide an effect estimate. Without counts, denominators, and an analysis, readers cannot assess the frequency of synechiae, the size of a contrast, or its uncertainty. Listing secondary outcomes likewise does not establish that they were measured or analyzed.

Finally, planning assumptions are not evidence about observed treatment effects. The registry describes a sample-size planning illustration based on an observed effect, but no primary result is reported alongside it. Such planning material cannot replace the actual outcome analysis. For clinicians and researchers, the key statistical lesson is to assess the clarity of the design and the completeness of results before interpreting a treatment comparison.

15. 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 of the registry record is the absence of primary outcome results. It does not give the number of participants with synechiae, a denominator for the primary assessment, a comparative estimate, or an uncertainty measure. The registry also lists no analyses, so the planned or completed statistical approach cannot be assessed.

Design descriptions are inconsistent or incomplete. The official title describes a double-blind randomized controlled study, but masking is listed as single, allocation as NA, and the model as single group. The intervention description says each nostril receives one of each spacer, but assignment to nostrils and the handling of paired outcomes are not reported. The registry explicitly cautions that the arms are not a like-for-like control comparison. This complicates any attempt to treat the device entries as ordinary parallel treatment groups.

The study is marked terminated, but the reason for termination and its consequences for recruitment, follow-up, outcome collection, and analysis are not reported. Enrollment is recorded as 3. The record does not clarify whether all expected assessments were completed or whether the stated follow-up was achieved. Missing-data rules and analysis populations are also not reported.

Outcome timing and definitions are not fully specified. The primary outcome refers to synechiae after surgery, with follow-up described as expected to average 90 days, while the primary description also mentions 35-day inflammation assessment. The record does not state the primary synechiae assessment time or endpoint classification rule. Finally, safety counts are brief registry entries without event-level details or an explanation of ascertainment. Together, these omissions limit both clinical interpretation and statistical evaluation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery — NCT02627794.
• Registry record last updated 2017-11-17; status last verified 2017-10.
• Results first posted 2017-11-17.
• 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.

19. Record Summary

NCT02627794 concerns Restora™ steroid-eluting and Silastic spacers after endoscopic sinus surgery. The stated primary outcome is the incidence of middle meatal synechiae. The record lists Phase 3, enrollment 3, status terminated, a start of 2015-12, and primary completion of 2016-04.

The official title describes a double-blind randomized controlled study, but the recorded design fields list single masking, allocation as NA, and a single-group model. The intervention description says each nostril receives one of each spacer. Assignment and paired analysis details are not reported. The registry lists no analyses and does not report primary or secondary outcome results.

Safety entries record 0 serious adverse events, 0 other adverse events, and 0 deaths in each listed spacer group, with 3 at risk in each. These counts are descriptive and do not establish comparative safety. The registry record does not provide enough outcome or analysis information to determine the comparative effect or its precision.