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 Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes (NCT01551082), a registered phase not stated study. The primary outcome is Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01551082 |
| Phase | Phase not stated |
| Condition | Lung Cancer, Pneumothorax, Subcutaneous Emphysema |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Alliance of Cardiothoracic and Vascular Surgeons |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes patients who underwent thoracic resection by one surgeon and were discharged home with an air leak and a chest tube connected to a portable drainage device. Lung cancer, pneumothorax, and subcutaneous emphysema are listed as conditions. The record does not describe further eligibility criteria or the characteristics of the enrolled participants beyond its general arm description.
Intervention
The management approach of interest is discharge home with the chest tube still in place and connected to a portable drainage device while an air leak is present. The registry summary characterizes this as outpatient chest-tube management after thoracic resection. It does not provide a detailed clinical protocol for follow-up, device management, or decisions about subsequent care.
Comparator
No comparator arm is described in the registry record. The allocation method is not stated, and the record does not establish a like-for-like comparison between outpatient management and another approach. A comparative treatment effect therefore cannot be estimated from the registered information.
Primary question
The registered question was whether outpatient chest-tube management was associated with patient satisfaction and decreased length of stay without compromising patient outcomes. The primary outcome description gives a timeframe of 2 years, but it does not define a measurement scale, endpoint parameter, or specific outcome criteria. The record says the study was terminated and no data were collected for the outcome. It therefore documents the question the study intended to address, not an answer to that question.
3. Trial Design
The registry lists this study as an interventional study of type “other,” with a status of terminated. Its stated enrollment is 12. The record gives a start date of 2012-03 and a primary completion date of 2014-01. It does not report why the study was terminated.
The described management strategy was discharge after thoracic resection with an air leak and a chest tube attached to a portable drainage device. The arm description refers to patients treated by one surgeon over the past seven years, but it does not provide a corresponding control group or describe allocation to alternative management. Allocation is not stated. The record therefore does not support treating the described group as part of a randomized comparison or as a like-for-like control comparison.
The planned outcome description concerns patient satisfaction, length of stay, and whether patient outcomes were compromised. The primary timeframe is 2 years. The registry does not specify how satisfaction would be measured, how length of stay would be defined, which clinical outcomes would be assessed, or when those outcomes would be collected. These details are not reported in the registry record.
The study record lists one outcome measure and 0 analyses. Most importantly, its primary outcome entry states that the study was terminated and no data were collected for the outcome. The enrollment figure and adverse-event entries do not replace the missing outcome data, and they do not establish that the planned outcome assessments were completed. No protocol details, statistical analysis plan, or rationale for the enrollment target are reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Outpatient Chest Tubes |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Study was terminated and no data were collected for the outcome
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: patients older than 18 years old who underwent lung resection and were sent home with chest tubes
| Characteristic | Unit | Outpatient Chest Tubes |
|---|---|---|
| Participants analysed | 12 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 |
| Age, Categorical: >=65 years | Participants | 8 |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 2 |
| Region of Enrollment: United States | participants | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome description concerns the relationship between outpatient chest-tube management and patient satisfaction, decreased length of stay, and patient outcomes. These are clinically distinct concepts: satisfaction reflects patients’ reported experience, length of stay concerns time spent in care, and clinical outcomes concern events or health status. A clear endpoint definition is needed to determine how each concept is measured and how results should be interpreted.
The registry gives a timeframe of 2 years but does not specify a satisfaction instrument, a definition of length of stay, a list of clinical outcome events, or a method for combining or separately assessing these measures. It also does not state the analysis parameter or measurement unit. These details are not reported in the registry record.
In general, an endpoint is used to make a broad research question measurable and to guide data collection and analysis. Without its operational definition, readers cannot determine precisely what would count as an outcome, how results would be summarized, or what comparison would answer the question. Here, the registry explicitly states that no data were collected for the primary outcome. Thus, the endpoint description identifies an intended area of assessment but supplies no observed result about satisfaction, length of stay, or patient outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry states that the study was terminated and no data were collected for the primary outcome. The record therefore contains no reported estimate of the association between outpatient chest-tube management and patient satisfaction, length of stay, or other patient outcomes. It cannot show whether those outcomes changed, in which direction they changed, or how precisely any effect was estimated.
The record lists enrollment of 12, but enrollment alone is not an outcome. It does not show that the primary measures were collected for those participants, and the registry explicitly says they were not. The entry also lists 0 analyses. No primary-outcome estimate, confidence interval, hypothesis test, or analysis result is reported in the registry record. The title and brief summary describe anticipated or asserted benefits and safety, but those statements do not substitute for observed outcome data in this record.
The design information also limits causal interpretation. No comparator arm is described, and allocation is not stated. The registered arm description refers to patients receiving outpatient management; without a documented comparison group and a reported analysis, there is no basis for attributing differences in outcomes to the management strategy. Even if an outcome estimate had been reported, interpretation would depend on how participants were selected, how outcomes were measured, and how potential differences between groups were addressed. Those details are not reported in the registry record.
The adverse-event entry lists 0 serious events and 0 other events among 12 at risk in the outpatient chest-tube group. These are registry counts, not a substitute for the primary outcome assessment. They should be read narrowly as the entries recorded for adverse events, rather than as evidence that the study established the absence of harm. The deaths field is null, and no serious-event terms are listed.
The sample-size note describes planning illustrations based on an observed effect, but the primary outcome record says no data were collected and the analysis count is 0. An observed study effect is not documented in the registry record. Any planning values should therefore be understood only as illustrations under stated assumptions, not as findings from this study or as observed power. In sum, the record documents a research question and limited registry entries, but it provides no analyzed primary-outcome evidence with which to answer the question.
9. Statistical Methods Explained
The registry identifies the study as type “other” and status “terminated.” Its description is not a conventional randomized comparison: allocation is not stated, and no comparator arm is described. The listed group concerns outpatient chest tubes after thoracic resection. The study record does not provide enough design detail to infer how participants were selected or whether any alternative management group was planned. Those details are not reported in the registry record.
What would an endpoint definition contribute?
In general, an endpoint definition specifies what is measured, how it is measured, and the time at which it is assessed. That definition allows readers to distinguish a planned concept from an analyzable variable. The primary description mentions satisfaction, length of stay, and patient outcomes, but does not set out a measurement scale, operational criteria, or a method for relating these distinct outcomes. The record gives a timeframe of 2 years, but the exact timing and procedures for assessment are not reported in the registry record. Because no outcome data were collected, there is no endpoint estimate to interpret.
What can an estimate and confidence interval tell a reader?
In general, an estimate describes the result calculated from observed data, while a confidence interval describes the statistical uncertainty around that estimate under the analysis assumptions. A narrow interval generally indicates greater precision than a wide interval, but precision does not by itself establish that an effect is clinically important or that a causal interpretation is justified. This registry record reports no primary-outcome estimate or confidence interval. Consequently, it offers no basis for judging either the magnitude or precision of an effect on satisfaction, length of stay, or patient outcomes.
What does the planning note mean?
The registry's sample-size note describes planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. It also distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. These are assumptions for planning examples, not documented features of the study's actual design. They do not establish that the registered study used equal allocation, had two arms, or enrolled participants according to those assumptions.
The note describes the illustrations as computed from an observed effect, yet the primary outcome entry states that no data were collected, and the record lists 0 analyses. No observed primary-outcome effect is documented. Thus, readers should not interpret such planning illustrations as a trial result or as observed power. Planning calculations estimate what a future design might require under specified assumptions; they do not show how much power an already completed study actually had.
Why do design and analysis details matter?
In general, a comparator and a clearly described allocation process help define the contrast being estimated. A statistical model or summary method then links the observed measurements to that contrast. When group membership is not described, or when no comparison is reported, a numerical treatment contrast cannot be interpreted as a causal effect merely because an intervention is named. In this record, the allocation method, a comparator, the analysis method, and the endpoint parameter are not reported in the registry record. No model assumptions or inferential results are available to assess.
Over-dispersion is a general concern when count data vary more than a chosen statistical model expects; failing to account for it can make uncertainty appear too small. This concept does not indicate that over-dispersion occurred in this study. The registry does not report a count-outcome analysis or any model to which that concern can be applied. Likewise, no information is reported about clustering, repeated measurements, or adjusted analyses.
In general, statistical interpretation requires more than a headline claim: it depends on the measurement definition, the study design, the analysis population, the model, and uncertainty around the estimate. Those elements cannot be reconstructed from the available registry entries. The appropriate statistical conclusion is limited: the record documents the intended clinical question and some descriptive fields, but it does not document a primary-outcome analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and 0 analyses. It does not report a multiplicity strategy, such as how inferential testing would be handled across multiple outcomes or comparisons. The primary description itself refers to satisfaction, length of stay, and patient outcomes, but does not say whether these were separate endpoints, components of one endpoint, or descriptive aims. The hierarchy of outcomes and any adjustment for multiple testing are not reported in the registry record.
The record states that no data were collected for the primary outcome. This is different from a reported analysis in which some outcome values are missing: there is no primary-outcome dataset described from which to assess missingness, imputation, or sensitivity analyses. Methods for handling missing data are not reported in the registry record. The reasons no data were collected are also not reported in the registry record.
The registry does not define an analysis population or state whether analyses were intended to include all enrolled participants, participants who received the described management, or another subset. A participant flow, exclusions, protocol deviations, and analysis denominators for the primary outcome are not reported in the registry record. Enrollment of 12 does not establish the number with evaluable outcomes, especially because the record says no outcome data were collected.
Without outcome data, an analysis population, and a stated multiplicity approach, there are no primary-outcome estimates or inferential findings to evaluate. The adverse-event counts are separate registry entries and do not resolve these gaps in the planned efficacy and outcome assessment.
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 |
|---|---|---|---|
| Outpatient Chest Tubes | 0 | 12 | 0.0% |
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 |
|---|---|
| Outpatient Chest Tubes | 0 of 12 |
The adverse-event record lists the outpatient chest-tube group with 12 at risk for serious events and 0 affected. It also lists 12 at risk for other events and 0 affected. No serious-event terms are listed. The deaths field is null, which means a death count is not reported in the registry record; it should not be read as a recorded zero.
These entries are descriptive registry counts. The record does not provide event definitions, event-collection procedures, follow-up completeness, or a detailed safety analysis. In particular, the primary outcome entry states that the study was terminated and no data were collected for that outcome. The adverse-event fields do not establish that all relevant safety outcomes were systematically assessed or that the study had sufficient information to characterize uncommon events.
In general, a zero count in a registry field describes what is entered in that field; it does not, by itself, prove that the underlying risk is absent. Here the counts should be reported as recorded, without converting them into a rate or treating them as evidence of comparative safety. No comparator is described, so the entries cannot establish a difference in safety between management approaches.
12. What the Result Does, and Does Not, Mean
The registry record establishes that outpatient chest-tube management after thoracic resection was the subject of a study whose intended outcomes included patient satisfaction, length of stay, and patient outcomes. It also records enrollment of 12, a status of terminated, and a primary outcome timeframe of 2 years. These registry entries describe the registered study, not its clinical effectiveness.
The record does not establish that outpatient management improved satisfaction or reduced length of stay. It also does not establish that outcomes were unchanged or that the approach compromised outcomes. The primary outcome entry explicitly states that no data were collected. Without observations, an analyzed comparison, and estimates of uncertainty, neither a favorable nor an unfavorable effect can be quantified from this record.
The title and brief summary state conclusions about cost effectiveness, safety, satisfaction, and outcomes, but the registry's primary outcome entry supplies no collected data to substantiate those claims as findings of this study. Cost effectiveness is not listed as a measured primary outcome, and economic methods or results are not reported in the registry record.
The adverse-event entries record 0 serious events and 0 other events among 12 at risk, but those fields cannot be expanded into a claim of no risk or comparative safety. Deaths are not reported as a count. The record does not give the event definitions or enough detail about ascertainment to interpret the entries beyond their recorded form.
The practical statistical meaning is therefore limited. The study raises a question about a management strategy, but the registry record does not provide outcome evidence with which to answer it. It neither demonstrates benefit nor demonstrates lack of benefit, and it does not establish equivalence, noninferiority, or safety. Those conclusions would require defined endpoints, collected observations, a suitable analysis, and a reported comparison; these are not available in the record.
13. Why This Trial Matters Statistically
This record illustrates why a stated clinical hypothesis and an analyzed result are different kinds of evidence. The title and summary describe potential benefits of outpatient chest-tube management, while the primary outcome entry says the study was terminated and no data were collected. A reader must distinguish the motivation or anticipated conclusion from an estimate based on observed outcomes.
It also shows why a comparison needs to be clearly specified. The registry describes outpatient chest-tube management but does not describe a comparator arm, and allocation is not stated. Without a documented contrast, a statistical effect comparing management strategies cannot be identified from the registry information. Naming a treatment approach is not equivalent to reporting a controlled comparison.
Endpoint definition is another key issue. Satisfaction, length of stay, and patient outcomes are not interchangeable measurements. The record does not define how they would be assessed or analyzed. Without those details, even a hypothetical result could be difficult to interpret, because readers would not know what the reported outcome represented.
The record also cautions against overreading descriptive safety entries. Recorded zero counts do not, on their own, establish that harms are absent, especially when event definitions and collection methods are not described. Statistical interpretation depends on the completeness and meaning of the data, not just the visible count.
Finally, planning calculations must be separated from trial results. Illustrations based on assumptions are not observed power and cannot fill the gap left by uncollected outcomes. This record matters statistically because it demonstrates the boundary between a registered research question and evidence capable of answering it: when outcome data and a documented comparison are absent, conclusions about effect and precision are not available.
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.
A central limitation is explicit in the registry: the study was terminated and no data were collected for the primary outcome. As a result, there is no primary-outcome estimate, uncertainty interval, or inferential analysis to assess. The reason for termination is not reported in the registry record.
The described outpatient chest-tube group is not accompanied by a stated comparator, and allocation is not stated. The registry does not explain how participants entered the group or whether another management approach was evaluated. This prevents a comparative interpretation and leaves the potential for selection differences unaddressed.
The primary outcome description combines satisfaction, length of stay, and patient outcomes without specifying measurement instruments, operational definitions, or a clear analysis parameter. Although a timeframe of 2 years is listed, outcome-assessment timing and procedures are not described. These endpoint details are not reported in the registry record.
The registry does not report a statistical analysis plan, analysis population, missing-data approach, multiplicity strategy, or model specification. The record lists 0 analyses. It also does not provide a reason for the planned enrollment figure, details of participant flow, or information about protocol deviations. These omissions mean that the study's planned analytic choices cannot be evaluated.
The adverse-event entries are limited to recorded counts and at-risk figures; event definitions, collection procedures, follow-up completeness, and a death count are not reported. Finally, the sample-size note describes planning illustrations using an observed effect, while the primary outcome record states that no data were collected. No observed primary-outcome effect is documented, so those illustrations cannot serve as evidence of an effect from this study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes — NCT01551082.
- Registry record last updated 2016-12-12; status last verified 2016-10.
- Results first posted 2016-12-12.
- 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.
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18. Record Summary
The registry record concerns outpatient chest-tube management following thoracic resection, with a stated enrollment of 12. It lists a start date of 2012-03, a primary completion date of 2014-01, and a status of terminated. The intended primary question concerned satisfaction, length of stay, and patient outcomes over a timeframe of 2 years.
The record describes discharge home with an air leak and a chest tube connected to a portable drainage device. It does not describe a comparator arm, and allocation is not stated. The primary outcome entry says no data were collected; the record lists 0 analyses. Accordingly, there is no reported primary-outcome result or comparative effect to interpret.
Adverse-event entries record 0 serious events and 0 other events among 12 at risk in the described group; deaths are not reported as a count. The reason for termination and key endpoint, analysis, and data-collection details are not reported in the registry record.