Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance (NCT00962650), a na na study. The primary outcome is Completion of Diagnostic Peritineoscopy.

2. Clinical Question

3. Trial Design

This completed study is described as a feasibility trial of natural-orifice transgastric endoscopic diagnostic peritoneoscopy with laparoscopic assistance. It had a single-group model, enrollment of 7, and no masking. The intervention is listed as a device procedure involving transgastric diagnostic peritoneoscopy with laparoscopic assistance. The registry record identifies Ethicon Endo-Surgery as the sponsor.

The stated population was individuals scheduled for Rouen Y gastric bypass, described as the intent-to-treat population. Abdominal adhesions are listed as a condition. The record does not provide detailed eligibility criteria, participant characteristics, or a separate description of how the analyzed population was defined. Allocation is listed as NA, and no control arm is described. As a result, the design addresses procedural feasibility rather than a comparative treatment effect.

The primary outcome description focuses on whether transgastric access was achieved using the EES NOTES GEN1 Toolbox, followed by completion of diagnostic peritoneoscopy using a flexible, steerable trocar. Its assessment interval was intra-operative, from first insertion of the flexible trocar into the oral cavity to final withdrawal. The registry record states that success was based on completion of the procedure after transgastric access.

The device arm description also says that multiple devices designed for trans-orifice use during surgical procedures were used for transvaginal cholecystectomy in this trial. That wording differs from the named transgastric intervention; the registry record does not clarify the relationship between these descriptions. A statistical analysis was not reported, and the record states that there was no statistical analysis.

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: All enrolled subjects provided informed consent to participate in the study, met protocol entry criteria, and had the study procedure attempted (ITT population).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.

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 Completion of Diagnostic Peritineoscopy, measured over Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar.

The primary endpoint is a count of participants in whom transgastric access was achieved using the EES NOTES GEN1 Toolbox. The outcome description connects that access to completion of diagnostic peritoneoscopy with a flexible, steerable trocar. The record describes the goal as assessing whether the procedure could be completed after transgastric access, making the endpoint a measure of procedural feasibility rather than a comparative estimate of clinical benefit.

The assessment was intra-operative and was timed from the first insertion of the flexible trocar into the oral cavity to its final withdrawal. This specifies the period over which the procedure was assessed, but the endpoint itself is a participant count, not a time-to-event measure. No duration result is reported in the registry record.

For a feasibility study, a count of completed procedures can directly describe whether the intended procedural steps were accomplished in the study population. Interpretation depends on the number of participants who met the outcome and the denominator used. The registry record describes the outcome definition but does not report the number who achieved it. It therefore does not permit a reader to quantify the observed completion experience from the primary outcome entry.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is identified as single-group, with allocation listed as NA and masking listed as none. In a single-group design, participants receive the study procedure without a concurrent control group. General statistical interpretation: such a design can describe what occurred in the observed group, but it does not directly estimate how outcomes would differ under another procedure or care strategy. Here, the registry record does not report the primary outcome count, so even a descriptive completion proportion cannot be recovered from the posted results.

What does a participant count represent?

The primary outcome is a count of participants in whom transgastric access was achieved using the specified toolbox. The description also defines procedural completion after access. General statistical explanation: a binary outcome classifies each participant according to whether a specified event occurred, and the count records how many participants fall into the event category. To interpret that count as a rate, the relevant denominator must also be clear. The registry record gives enrollment of 7, but does not give the primary outcome count. It therefore does not support a numerical rate or an uncertainty estimate for the primary endpoint.

The endpoint’s intra-operative timing identifies when the procedural assessment takes place: from first insertion of the flexible trocar into the oral cavity to final withdrawal. The outcome is not described as elapsed time, despite the timing language. It is described as the number of participants with access achieved and the procedure completed. No procedure-duration statistic is reported in the registry record.

Why does uncertainty matter?

General statistical explanation: an estimate from a study is subject to sampling uncertainty, especially when based on a small group. A confidence interval is a range of values compatible with the observed data under a stated statistical method; it helps communicate precision rather than only a single estimate. No confidence interval is reported for this endpoint, and the absent outcome count prevents an independent descriptive estimate from being established from the registry record. No hypothesis-test result or p-value is reported either.

General statistical explanation: standard errors and confidence intervals for a binary outcome depend on the observed event count and the denominator, as well as the method used. Different methods can behave differently when counts are small or at the boundaries of the possible range. Since the primary event count is not reported, selecting or discussing a numerical interval would require information that is not reported in the registry record. The record also says there was no statistical analysis, so it does not identify an interval method to interpret.

What can an analysis plan establish?

A statistical analysis plan typically specifies how outcomes and populations will be analyzed, what summaries or models will be used, and how uncertainty or multiple testing will be handled. General explanation: prespecifying these decisions can clarify how the study will answer its question and reduce ambiguity when interpreting results. A statistical plan is not reported in the registry record. The record states that there was no statistical analysis and lists zero analyses. It does not report interim analyses, a sample-size justification, or a model for the primary endpoint.

The record includes planning assumptions for separate sample-size illustrations: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a fraction of the observed effect. It also specifies that time-to-event illustrations would count total events, while other illustrations would give participants per arm. These are planning assumptions, not a description of this trial’s single-group design. Numerical sample-size outputs are not reported in the registry record. Such illustrations are planning quantities and are not observed power or evidence of the result of this feasibility trial.

How should the design shape interpretation?

General statistical explanation: with no comparator, a study can describe the observed experience in its enrolled participants but cannot separate the intervention’s contribution from other influences or estimate a treatment contrast. That distinction is especially important when the outcome is procedural completion. The record frames the endpoint as feasibility, but without a reported outcome count, it provides no numerical estimate of how often completion occurred. There is also no adjusted analysis or comparative estimate to interpret.

The registry record reports enrollment of 7, one listed outcome measure, and zero analyses. These registry entries describe the amount of study and analysis information recorded, but do not substitute for the missing endpoint result. The absence of a statistical analysis means there is no reported inferential result; it does not establish that the procedure succeeded or failed. The posted registry information supports a description of the design and endpoint, while leaving the main numerical finding unresolved.

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("Natural Orifice Transgastric Diagnostic Peritineos")
n      <- c(10)
events <- c(8)
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  Natural Orifice Transgastric Diagnostic Peritineos  10  8  80.0  44.4  97.5  49.0  94.3  48.2  94.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and zero analyses. It also states that there was no statistical analysis. No multiplicity adjustment is reported in the registry record. With no reported hypothesis tests or analysis results, there is no family of statistical tests in the posted results for which an adjustment can be assessed. The primary endpoint is described, but its count is not reported.

Missing-data handling is not reported in the registry record. The record does not state whether any participant had a missing primary outcome, how an incomplete procedure would be classified, or whether any observations were excluded from the endpoint summary. The enrollment figure of 7 does not establish that all participants contributed to the primary endpoint. No imputation or other missing-data method is reported.

The population description identifies individuals scheduled for Rouen Y gastric bypass as the intent-to-treat population. The registry record does not provide a separate analyzed population, an analysis denominator for the primary endpoint, or a participant flow accounting. Although it reports enrollment, the primary outcome count and its denominator are not stated together. Therefore, the posted information does not show whether the intended population and endpoint population were identical.

These omissions limit assessment of how robust the endpoint result would be to missing observations or alternative analysis choices. Because no statistical analysis is reported and the outcome result itself is unavailable, the registry record does not support conclusions about multiplicity control, missing-data sensitivity, or consistency across analysis populations.

12. 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

Serious events with the highest arm-level rate: esophageal injury/ oesophageal injury (10.0%).

The registry safety entry lists 10 participants at risk for serious adverse events and 1 affected. It lists 10 participants at risk for other adverse events and 0 affected. Esophageal injury/oesophageal injury is the leading serious adverse event term, reported as 10.0%. Deaths are not reported in the registry record.

These counts describe the safety entry as recorded; they are not a comparison with another group. The safety denominator of 10 differs from the overall enrollment of 7. The registry record does not explain this difference, so the two figures should not be treated as if they share a reconciled population. The reported term and percentage should be read as registry safety information, not as a causal assessment of the device or procedure.

General statistical explanation: adverse-event counts describe observed reports, and their interpretation depends on how events and participants at risk were defined and captured. A count by itself does not establish why an event occurred. No further event-level context, severity detail beyond the serious-event classification, or analysis of the safety data is reported in the registry record. The available entries therefore support a limited description of reported counts, not a broader comparative safety conclusion.

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

The study’s stated purpose was to document whether transgastric diagnostic peritoneoscopy could be performed using a small collection of study surgical tools. Its primary endpoint was intended to capture whether transgastric access was achieved and peritoneoscopy completed. This is a feasibility question about performing a procedure in the specified study population, not a direct test of comparative clinical benefit.

The registry record does not report the number of participants who achieved the primary outcome. As a result, the central feasibility result cannot be quantified from the posted information. Enrollment of 7 does not tell the reader how many procedures were completed. The record also reports no statistical analysis, so it provides no primary-outcome estimate with which to assess precision.

The single-group design has no comparator. Even if a completion count were reported, that design would describe the experience in the study group rather than estimate how outcomes compare with another approach. The registry information does not support a claim that the procedure is more or less effective or safer than another option.

The safety entry reports serious and other adverse-event counts, including the leading serious term. The difference between the safety denominator and enrollment is not explained in the registry record, and the available information does not establish an event’s cause. These safety figures should therefore be interpreted narrowly as reported registry counts.

In general, feasibility findings can inform whether further evaluation of a procedure is worth considering, but they do not by themselves resolve questions of comparative outcomes. For this study, the registry record states the feasibility objective and outcome definition, yet does not report the primary result. The completed status indicates the study is recorded as completed; it does not supply the missing outcome count or provide evidence beyond the information actually reported.

14. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a clear feasibility question and a reportable feasibility result. The registry record defines an intra-operative procedural outcome and identifies the intended population and intervention. Those details make the question understandable: whether transgastric access and diagnostic peritoneoscopy could be completed with the specified tools. But the registry record does not report the number of participants who achieved the endpoint, so the main quantity needed to answer that question is unavailable.

The study also illustrates how design determines the scope of inference. A single-group feasibility trial can be oriented toward documenting procedural completion, but it does not provide a randomized or otherwise controlled contrast. Statistical interpretation must remain descriptive and limited to the observed group, even if the primary outcome result is available. Here, the absence of that result further limits what can be concluded.

Reporting denominators is another important issue. Enrollment is listed as 7, while the safety entries give 10 participants at risk. The registry record does not explain the difference. This does not justify choosing one denominator over the other for a different outcome; instead, it highlights why outcome-specific populations and denominators need clear explanation.

Finally, the record states that there was no statistical analysis and lists zero analyses. That makes it important to separate a study objective from an analyzed finding. The endpoint definition and safety counts are informative about what the registry records, while the missing primary count, uncertainty estimate, and analysis details constrain interpretation. This case shows that sound statistical reading includes recognizing when the design is clear but the result is not sufficiently reported.

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 primary limitation for interpreting the feasibility question is that the registry record does not report the primary outcome count. Although the endpoint is defined and enrollment is stated, readers cannot determine how many participants achieved transgastric access or completed diagnostic peritoneoscopy. No estimate of endpoint precision is reported, and there was no statistical analysis.

The study has a single-group design and no comparator. This restricts interpretation to the study procedure as described and prevents a controlled estimate of differences relative to another intervention. The registry record does not report a statistical plan or sample-size justification, so the basis for the enrollment target and the intended inferential approach are not reported in the registry record.

The safety denominator is 10, while overall enrollment is 7. The registry record does not explain this difference. It also does not report deaths, participant flow, or missing-data handling. These omissions make it difficult to understand which participants contributed to the safety and primary-outcome summaries, especially because the primary outcome denominator is not reported.

The record’s intervention descriptions are not fully aligned: the named procedure is transgastric diagnostic peritoneoscopy with laparoscopic assistance, while the device arm description refers to use for transvaginal cholecystectomy in this trial. The registry record does not clarify this wording. Detailed participant characteristics, procedural results beyond the endpoint definition, and additional event context are also not reported in the registry record. These limits call for a narrow reading of the posted information rather than assumptions about the protocol or unreported findings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance — NCT00962650.
• Registry record last updated 2012-03-29; status last verified 2012-03.
• Results first posted 2012-03-29.
• 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

This completed, single-group feasibility trial evaluated transgastric diagnostic peritoneoscopy with laparoscopic assistance in individuals scheduled for Rouen Y gastric bypass. The registry record lists enrollment of 7 and a primary outcome based on achieving transgastric access and completing diagnostic peritoneoscopy. It describes intra-operative assessment but does not report the primary outcome count or a statistical analysis.

The safety entry reports 1 serious adverse event among 10 at risk, 0 other adverse events among 10 at risk, and esophageal injury/oesophageal injury as the leading serious term at 10.0%. The difference between the safety denominator and enrollment is not explained, and deaths are not reported in the registry record. With no comparator and no primary result, the posted information supports a description of the study’s question and recorded safety figures, but not a numerical conclusion about procedural completion or a comparative effect.