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 Fluorescent Evaluation of Colorectal Anastamoses (NCT01424293), a na na study. The primary outcome is Evaluate the Vascular Supply of the Bowel Intra-operatively and Correlate This With Postoperative Complications Identified During Their Hospital Stay at One Week and One Month Postoperatively..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01424293 |
| Phase | NA |
| Condition | Rectal Neoplasms, Colon Neoplasms, Diverticulitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Maimonides Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes bowel surgery and lists rectal neoplasms, colon neoplasms, and diverticulitis as conditions. The study is framed around evaluating bowel perfusion during an operation and identifying complications afterward. Specific eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The listed intervention is 1ml of intravenous indocyanine green, with transanal imaging using the SPY® system. The registry describes the system as a special camera used to evaluate blood supply to the bowel during surgery. Further procedural details are not reported in the registry record.
Comparator
No separate comparator group is listed. The record describes a single-group study, with allocation marked NA and masking marked NONE. It therefore does not provide a concurrent control group for a like-for-like comparison of imaging with another approach.
Primary question
The primary objective is to evaluate bowel vascular supply during the operation and relate that assessment to postoperative complications identified during the hospital stay and at follow-up. The listed outcome is a number of complications over 30 days. The registry record does not report the primary outcome result or a statistical estimate of the relationship.
The clinical rationale in the record is that inadequate blood supply may contribute to leakage where bowel ends are reconnected, while the cause of leakage is not fully understood. The study uses intraoperative imaging to assess perfusion and then describes follow-up for complications. That objective is different from testing whether the imaging system reduces complications: a reduction would require a suitable comparison and reported outcome data. Neither a comparator group nor primary outcome results are reported in the registry record.
3. Trial Design
The record describes a completed, single-group study sponsored by Maimonides Medical Center. Enrollment is listed as 7. The phase is NA, allocation is NA, and masking is NONE. The registry lists indocyanine green and the SPY® Intraoperative Imaging System as device interventions. The intervention description specifies intravenous ICG and transanal imaging with the Spyscope system.
The registry dates the study start to 2010-05 and primary completion to 2016-09. These dates describe the record’s study timeline; they do not establish how long each participant was followed. The outcome description says participants would be followed through the hospital stay and at 1 week and 1 month postoperatively, with a 30-day timeframe listed for the primary outcome.
Because there is no separate control group, the design cannot make a direct concurrent comparison between the imaging approach and an alternative. The record does not report a protocol, eligibility criteria, recruitment details, or whether all enrolled participants contributed outcome data. It also does not describe a randomization procedure, which is consistent with allocation being listed as NA, but the reasons for the design choices are not reported in the registry record.
The registry marks the study as COMPLETED. Completion status alone does not show that the planned outcome was measured or that results were posted. No primary analysis is listed, and the registry record does not report a sample-size justification or a detailed statistical analysis plan.
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 | Indocyanine Green |
|---|---|
| STARTED | 7 |
| COMPLETED | 7 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Indocyanine Green |
|---|---|---|
| Participants analysed | 7 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 5 |
| Age, Continuous | years | 70.29 (SD 11.44) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Evaluate the Vascular Supply of the Bowel Intra-operatively and Correlate This With Postoperative Complications Identified During Their Hospital Stay at One Week and One Month Postoperatively., measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Complications |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is described as an intraoperative evaluation of bowel perfusion related to postoperative complications. Its listed unit is complications, its parameter is a number, and its timeframe is 30 days. The description says participants would be followed during the hospital stay and at 1 week and 1 month postoperatively to identify complications.
This outcome links an observation made during surgery with events occurring afterward. In general, measuring complications can help describe the clinical course after an operation, while a perfusion assessment may provide information about blood supply at the time of reconstruction. The endpoint’s stated purpose is to evaluate vascular supply and correlate it with complications; the record does not specify how perfusion was quantified, which complications counted, or how the relationship would be analyzed.
The registry record does not report a primary outcome value, an estimate of association, or uncertainty around an estimate. The listed objective and follow-up schedule therefore describe what the study intended to assess, not what its results established.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes that enrollment was 7 and that the study was completed as a single-group study. It lists an outcome concerning intraoperative bowel perfusion and postoperative complications, but does not post a result for that outcome. The number of primary outcome analyses is listed as 0. Consequently, the registry record does not provide an observed complication count for the primary endpoint, a measure of perfusion, or an estimate linking perfusion to complications.
Without a posted outcome estimate, the size and precision of any observed relationship cannot be evaluated. In general, an estimate describes the magnitude of a finding, while a confidence interval describes the range of values compatible with the data under the method used. Neither an estimate nor a confidence interval for the primary outcome is reported in the registry record. A p-value or other test result is also not reported.
The single-group design is important when interpreting the objective. A description of outcomes among participants who received the imaging procedure would not, by itself, establish what would have occurred under a different approach. The record lists no comparator group, and it explicitly does not represent a like-for-like control comparison. Thus, even if a primary result were posted, a causal contrast between the imaging approach and an alternative could not be read from this registry entry as described.
The adverse-event section lists 7 participants at risk for serious adverse events and 0 affected; it also lists 7 at risk for other adverse events and 0 affected, with 0 deaths. These are the registry’s recorded counts. They should be interpreted as entries in the safety record rather than as a detailed account of all events, because event definitions, collection procedures, and further safety details are not reported in the registry record.
Planning illustrations associated with the record are described as hypothetical calculations based on a fraction of an observed effect, with equal allocation between two arms, a two-sided significance level of 0.05, and a normal approximation. They are planning illustrations, not observed power and not results from this single-group study. Their assumptions do not turn this design into a two-group comparison. The numeric details of a sample-size justification for the actual study are not reported in the registry record.
Overall, the posted information supports a description of the study’s objective, design, enrollment, and recorded safety counts. It does not support a statistical conclusion about the primary endpoint or a comparison of outcomes between alternative approaches.
9. Statistical Methods Explained
The registry record describes the study as single-group and lists no primary analyses. It does not report an analysis method for the primary outcome. The concepts below explain how such data could be considered in general; they are not claims about methods used in this study.
What does a count outcome describe?
In general, a count outcome records how many events meet a defined outcome rule. For this study, the registered outcome is expressed as a number of complications over 30 days. To interpret such a count, readers need to know the event definition, how events were collected, whether more than one event per participant could be counted, and how follow-up was handled. Those details are not reported in the registry record.
Counts can be presented as totals or alongside the number of participants observed. A total alone does not show how events were distributed across participants, and a participant-level count may differ from an event total if a participant can have multiple events. The record gives an enrollment count, but does not report the primary complication result or the number of participants included in a primary outcome analysis. It is therefore not possible to reconstruct a rate or an analysis denominator from the registry entry.
How would an association be interpreted?
The stated objective includes relating intraoperative perfusion assessment to postoperative complications. In general, an association analysis would need a clearly defined perfusion measure and a specified way of relating that measure to the outcome. The registry does not say whether perfusion was categorized or retained as a measurement, nor does it report a model, an association estimate, or its uncertainty. A correlation, if calculated, would describe how two observed measures vary together; it would not by itself establish that one caused the other.
In general, a confidence interval communicates uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but the interval does not resolve limitations in study design or measurement. No confidence interval for the primary objective is reported in the registry record. A p-value, if used, would address compatibility of the data with a specified null hypothesis under a chosen statistical procedure; it would not quantify clinical importance. No p-value or hypothesis-testing procedure is reported.
Why does the single-group design matter?
In general, a concurrent comparator helps distinguish outcomes associated with an intervention from outcomes that may have occurred for other reasons. This record has a single group and no like-for-like control comparison. Descriptive findings, if reported, could characterize the participants and outcomes recorded in that group, but they could not directly estimate a between-group treatment contrast. Adjustment for measured characteristics would not create a concurrent control group, and no adjusted analysis is reported.
What do the planning assumptions mean?
The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrations are said to target a stated fraction of an observed effect. In general, a sample-size calculation asks how much information a proposed design would need for a specified effect and assumptions. Changing the target effect or assumptions changes the planning result. These illustrations do not describe the observed precision of this study and are not observed power. Their two-arm allocation assumption is distinct from the registry’s single-group design.
In general, calculations for count outcomes may depend on the expected event frequency and variability. Over-dispersion matters when count data vary more than a model’s assumed distribution allows: if it is ignored, uncertainty may be understated. Whether the study used a count model, assessed over-dispersion, or made assumptions about event variability is not reported in the registry record. No model specification or dispersion estimate is posted.
The distinction between an intended statistical method and a reported analysis is essential. An outcome description and a planning illustration do not establish that a particular model was used. The registry lists 0 primary analyses and does not report an analysis population, missing-data approach, or inferential result. Any interpretation beyond the stated design and recorded counts would therefore require information not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure, but its description refers to complications identified during the hospital stay and at 1 week and 1 month postoperatively. The record does not say whether these observations were analyzed separately, combined into one outcome, or treated as repeated assessments of the same outcome. It also does not list a multiplicity strategy or explain how multiple complication types, if assessed, would be handled.
In general, multiplicity arises when several outcomes, time points, subgroups, or statistical tests are examined. Looking across multiple tests can increase the chance that at least one result appears notable by chance. Prespecified outcome definitions and an analysis plan help readers distinguish planned analyses from exploratory ones. The registry record does not report such a plan or a method for addressing multiplicity.
Information about missing data is not reported in the registry record. It does not state whether all enrolled participants completed follow-up, how missing visits or incomplete outcome information would be handled, or whether any sensitivity analyses were planned. Enrollment is listed as 7, but the number contributing to the primary outcome analysis is not reported.
The analysis population is also not described. The registry does not specify whether analyses were intended to include everyone enrolled, only participants who received the intervention, or another defined group. These omissions limit assessment of how participants and outcomes would enter an analysis. They do not establish that data were missing or that participants were excluded; they mean the relevant handling is not reported in the registry record.
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 |
|---|---|---|---|
| Indocyanine Green | 0 | 7 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Indocyanine Green | 0 of 7 |
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 |
|---|---|
| Indocyanine Green | 0 of 7 |
The safety entry for the Indocyanine Green group lists 7 participants at risk for serious adverse events and 0 affected. It also lists 7 at risk for other adverse events and 0 affected, with 0 deaths. These are the recorded counts in the registry.
In general, an “at risk” count identifies the denominator used for the safety entry, while an “affected” count records participants with an event under the registry’s reporting categories. These figures should not be expanded into claims about event types or collection methods that are not described. The registry does not list top serious adverse-event terms, and definitions, surveillance procedures, and the completeness of reporting are not reported in the registry record.
The zero counts are not a statistical demonstration that the risk of an event is absent. They are a description of what the safety record reports for this group. With no comparator group and no additional safety detail, the counts do not establish a comparative safety difference or characterize risks beyond the recorded participants.
12. What the Result Does, and Does Not, Mean
The record documents a small, completed, single-group study that set out to evaluate bowel perfusion during an operation and relate that assessment to postoperative complications. It identifies the imaging intervention, the intended follow-up, enrollment, and safety counts. These registry entries describe the study’s scope and what the registry records.
The record does not report the primary endpoint result, a perfusion measurement, an association estimate, a confidence interval, or a statistical test. As a result, it cannot show how often the specified complications occurred in the study group or how closely they were related to the intraoperative assessment. No conclusion about the magnitude or precision of the primary finding can be drawn from the posted outcome information.
The design also limits what could be inferred from a result in this group. A single-group observation does not provide a concurrent comparison with another imaging method or usual practice. In general, outcomes after surgery can reflect multiple influences, so observing outcomes in one group alone cannot isolate the contribution of a particular assessment approach. The record does not report an analysis that addresses such influences.
The safety counts show that the registry lists 0 serious adverse events, 0 other adverse events, and 0 deaths among the recorded group entries. They do not establish that no possible adverse events occurred outside the registry’s reporting definitions or observation process, details of which are not reported.
The appropriate reading is therefore bounded: the registry describes an intended evaluation and a completed study, but does not provide the primary results needed to assess the stated endpoint. Completion status and planning calculations should not be mistaken for evidence of an outcome or for a comparison of approaches.
13. Why This Trial Matters Statistically
This study raises a statistical question that is broader than whether an imaging procedure was performed: how should an intraoperative measurement be related to outcomes that occur afterward? Answering that question requires a defined perfusion measure, a clear complication outcome, specified follow-up, and an analysis connecting the measures. The registry states the objective and follow-up schedule, but the measurement definition and primary analysis are not reported.
The single-group design also makes the distinction between description and comparison especially important. In general, a group’s observed outcomes can describe what happened among its participants. A comparison requires a suitable reference group and an analysis designed for that contrast. Here, no comparator group is listed, so any descriptive finding would not by itself identify the effect of the imaging approach relative to an alternative.
Small enrollment makes transparent reporting of participant flow, event definitions, and uncertainty particularly useful. The registry lists enrollment as 7, but does not report a primary outcome count or analysis denominator. Without these details, readers cannot assess the precision of the endpoint estimate or understand how individual observations contributed to a result.
The record also illustrates why planning assumptions must be kept separate from observed evidence. Its sample-size illustrations are described using two-arm assumptions, while the study is listed as single-group. Such illustrations are not observed power and do not substitute for the trial’s own reported design rationale, which is not reported in the registry record.
Statistically, the central value of a record like this depends on complete outcome reporting: the result, its uncertainty, the analysis population, and the method used to connect perfusion with complications. Those elements are not reported, so the objective can be understood but its statistical answer cannot be evaluated.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpretation is the absence of a posted primary outcome result. The registry specifies a complication outcome and a 30-day timeframe, but does not give the number of complications, a perfusion measure, or an estimate of their relationship. It also lists 0 primary analyses. There is consequently no reported effect estimate or measure of precision to assess.
The single-group structure does not support a direct comparison with an alternative approach. Allocation is listed as NA, masking as NONE, and no comparator group is described. A control comparison is not available from this record, and the registry does not report an adjusted analysis or other method intended to address differences in clinical circumstances.
Important design and measurement details are not reported in the registry record. These include eligibility criteria, participant characteristics, the operational definition of perfusion, the definition of a complication, and how the relation between intraoperative assessment and postoperative events was to be analyzed. The number contributing outcome data and the handling of incomplete follow-up are also not reported.
The enrollment count is 7. Without the primary outcome values and analysis denominator, the precision of any intended estimate cannot be judged. The safety section’s zero affected counts are limited to the registry entries and are not accompanied by event definitions or further information on ascertainment.
Finally, the planning illustrations are described with two-arm assumptions, which differ from the single-group study design. The registry does not report a study-specific sample-size justification. These gaps constrain interpretation of both the planned objective and the posted record; they do not establish what the unreported outcomes would have been.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fluorescent Evaluation of Colorectal Anastamoses — NCT01424293.
- Registry record last updated 2021-07-13; status last verified 2021-06.
- Results first posted 2021-07-13.
- 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 identifies NCT01424293, “Fluorescent Evaluation of Colorectal Anastamoses,” sponsored by Maimonides Medical Center. It describes a completed, single-group study with enrollment of 7, using indocyanine green and the SPY® Intraoperative Imaging System to evaluate bowel perfusion during surgery.
The primary objective concerns relating intraoperative vascular supply assessment to postoperative complications during the hospital stay and at 1 week and 1 month. The listed outcome is a number of complications over 30 days. The primary outcome result and analysis are not reported in the registry record.
The safety entry lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 7 participants at risk. There is no separate comparator group. The registry dates the study start to 2010-05 and primary completion to 2016-09.