A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis (NCT05739162), a na na study. The primary outcome is Percent Total Body Weight Loss.

2. Clinical Question

The research purpose is to gather information on the safety and effectiveness of ESG for weight loss among people with obesity and ulcerative colitis undergoing colectomy with eventual IPAA. The primary outcome is percent total body weight loss, calculated from screening baseline weight and follow-up weight. The intervention description places the lifestyle intervention after the procedure and a 6-week transitional diet.

This is a descriptive clinical question rather than a treatment-versus-control question. With no control arm, the study cannot directly estimate how outcomes would differ under another treatment or under no ESG. The registry record identifies secondary outcomes concerning peri-operative complications, gastrointestinal symptoms, pouchitis disease activity, and durable weight loss. Their presence indicates topics the study intends to assess, not that results for those topics are available.

3. Trial Design

The registry record classifies this study as a single-group study, with allocation listed as NA and masking listed as none. It does not describe a like-for-like control arm. The record lists enrollment as 2, while the primary outcome description says only 1 participant was randomized and explains that no data are reported because of the low enrollment number and participant privacy and confidentiality. These statements should be kept distinct: neither establishes a treatment comparison, and the primary outcome remains unavailable.

The study concerns ESG in people with obesity and ulcerative colitis undergoing colectomy with eventual IPAA. Participants in the ESG arm undergo the procedure. After the 6-week transitional diet following ESG, they start the lifestyle intervention. The Apollo Endoscopic Suture System and Lifestyle Intervention are listed as interventions. The study phase is recorded as NA.

The registry lists a start date of 2023-09-20, a primary completion date of 2025-07-01, and status active, not recruiting. These are registry-record details, not evidence that the outcome data have been posted. The stated purpose is to gather information on safety and effectiveness for weight loss in this clinical population.

A single-group design can describe outcomes observed after an intervention, but it does not by itself separate intervention-associated change from other influences over time. The registry record does not report a comparison group, allocation process, or masking beyond the entries noted above. It also does not report a detailed protocol or statistical analysis plan. Consequently, design features beyond those explicitly listed cannot be inferred.

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: 2 subjects were enrolled on the study, 1 of which screen failed prior to randomization. As only 1 participant was randomized in this study, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only 1 participant was randomized in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

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: Only 1 participant was randomized in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

6. Primary Endpoint

The registry lists the primary outcome as Percent Total Body Weight Loss, measured over 6 months.

The primary endpoint is Percent Total Body Weight Loss at 6 months. The registry defines it using screening baseline weight and follow-up weight: baseline weight in kilograms minus follow-up weight in kilograms, divided by baseline weight in kilograms, then multiplied by 100. The outcome is expressed as a percentage of a participant’s baseline body weight, rather than as an absolute weight change.

As a general statistical interpretation, expressing weight change relative to baseline can make change meaningful in relation to each participant’s starting weight. Under the stated formula, a follow-up weight below baseline produces a positive percent total body weight loss; the formula itself does not establish why the weight changed or whether the change is attributable to ESG.

A weight-loss measure is relevant to the study’s stated purpose of gathering information about ESG for weight loss in this population. The 6-month time point defines when the primary outcome is assessed; it should not be read as a measure of long-term durability. Durable weight loss is listed as a secondary outcome, but no result for it is posted in the registry record.

The registry does not report a numeric primary outcome value. It explains that only 1 participant was randomized and that data are not reported to protect and maintain participant privacy and confidentiality. As a result, the endpoint definition can be described, but the observed amount and precision of weight change cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design estimate?

In general, a single-group study records outcomes among participants receiving an intervention without a concurrent control group. It can describe what was observed in that group, if outcome data are available. It cannot, on its own, establish how those outcomes would have differed under another intervention or without the intervention. The registry classifies this study as single-group and lists allocation as NA; the record does not describe a comparator arm.

This distinction matters when interpreting a before-and-after endpoint. A change between baseline and follow-up is a within-participant change, not automatically an effect caused by the procedure. Other events, care, or changes over time could contribute. A concurrent control comparison can help address such questions, but none is described in this record.

What does the primary measure represent?

The primary outcome is percent total body weight loss at 6 months. It uses the difference between baseline screening weight and follow-up weight, divided by baseline screening weight, multiplied by 100. In general, a relative measure expresses a change in relation to a starting value, while an absolute measure expresses change in the original units. The registry’s formula specifies a relative measure.

That definition is not itself an outcome result. The record does not give the observed value or its uncertainty. A confidence interval, in general, describes the range of estimates compatible with the data and the statistical method used; it communicates precision, not certainty that the true value lies within a particular interval. No primary outcome confidence interval is reported in the registry record, so precision cannot be assessed.

Why is a sample-size calculation different from a trial result?

Planning sample-size illustrations are not observed results and are not observed power. The registry’s stated assumptions describe illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For those illustrations, the effect to detect is a stated fraction of the observed effect. The registry also distinguishes calculations expressed as participants per arm from time-to-event calculations expressed as total events.

These assumptions are explicitly described as planning illustrations, not as the design calculation used for this trial. The record does not report the trial’s own sample-size justification. It also does not provide a numerical observed effect for the primary outcome, because that outcome data are withheld for privacy and confidentiality. No numerical planning result can be interpreted from these details alone. In general, a sample-size illustration depends on assumptions about the effect to detect and the analysis; it is not evidence that a study had a particular probability of detecting an effect after completion.

What can be said about the statistical analysis?

The registry record lists zero analyses. It does not report an analysis method for the primary endpoint, an adjustment strategy, a model, or a statistical plan. Without those details and without a posted endpoint value, the analysis cannot be independently assessed. The absence of a listed analysis is not a basis for guessing which methods were used.

General statistical methods can address different features of data. For example, a mean may summarize a distribution of continuous measurements, while a model may adjust for specified factors or account for repeated measurements. The appropriate choice depends on the design, data structure, and analysis objective. None of these methods should be attributed to this study unless the registry record reports them.

Over-dispersion is a general issue for count outcomes: it occurs when observed variability exceeds what a chosen count model assumes. If unaddressed, uncertainty estimates from that model may not reflect the variability in the data. The registry lists complication outcomes as counts, but does not report an analysis model or enough outcome data to assess dispersion. This general concept therefore does not imply that over-dispersion was observed in this study.

How should the adverse-event entries be read?

The registry includes adverse-event fields for serious events, other events, and deaths. The group entries show zero at risk as well as zero affected. In general, an event count is interpretable in relation to the population observed and the period and methods used to collect events. When the at-risk count is zero, the zero event count cannot be treated as a rate or evidence that risk was absent. The record does not provide a usable safety estimate from these fields.

More broadly, statistical interpretation requires both an estimate and information about how it was obtained. Here, the registry describes a clinical question and outcome definitions, but the primary result and analyses are not posted. Statistical methods can clarify what an estimate would mean, but they cannot recover an estimate that is not reported.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome and five named secondary outcome topics, with seven outcome measures recorded overall. Listing multiple outcomes raises a general issue of multiplicity: when several hypotheses are examined, the chance of at least one apparently notable result can increase if results are interpreted without accounting for the number and relationships of the comparisons. The record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or another strategy for handling this issue. It would be inappropriate to infer one.

The record also lists zero analyses and does not report a statistical analysis plan. It does not describe methods for missing outcome data, rules for excluding observations, or how analysis populations were defined. These details are not reported in the registry record, so the handling of missingness and the exact population used for any analysis cannot be evaluated.

For the primary endpoint, the registry states that no data are reported because only 1 participant was randomized and because of participant privacy and confidentiality. This is a reason given for withholding the outcome, not a description of a statistical method for handling missing data. It does not tell readers whether the outcome was collected, how it was recorded, or whether any analysis was performed.

In general, missing-data methods rely on assumptions about why measurements are unavailable. Different assumptions can lead to different estimates, so transparency about the amount and pattern of missingness and the chosen method is important. Those details are not reported in the registry record. The absence of posted results also means that the effect of any missingness cannot be assessed.

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

The registry record establishes that the study concerns ESG for weight loss in people with obesity and ulcerative colitis undergoing colectomy with eventual IPAA. It describes a single-group intervention approach, a lifestyle intervention following a 6-week transitional diet after ESG, and percent total body weight loss at 6 months as the primary outcome. These registry entries describe the study question and planned assessment; they do not establish an outcome.

The primary outcome value is not reported in the registry record. The record explains that only 1 participant was randomized and that data are not reported to protect and maintain participant privacy and confidentiality. Consequently, there is no posted estimate of the amount of weight change, no stated uncertainty around it, and no basis to judge its precision. The absence of a result is not evidence of no change or of a particular direction of change.

The record does not describe a comparator group, so it cannot support a treatment-versus-control estimate. Even an available within-group change would not, by itself, show that the intervention caused the change. The registry also does not post interpretable safety results: adverse-event entries have zero at risk as well as zero affected. Those entries cannot demonstrate that no adverse events occurred.

Secondary outcomes are named, including peri-operative complications, gastrointestinal symptoms, pouchitis disease activity, and durable weight loss. Their listing does not mean that their results are available or favorable. No conclusion about these outcomes can be drawn from the information reported in the registry record.

The most defensible reading is therefore limited: the record identifies a clinical question and documents selected design and outcome details, but it does not permit an assessment of the observed primary outcome, its precision, or comparative effectiveness. It neither proves benefit nor proves lack of benefit. Any stronger conclusion would go beyond the posted results.

12. Why This Trial Matters Statistically

This study addresses a specific clinical context: obesity in people with ulcerative colitis undergoing colectomy with eventual IPAA. Statistical interpretation is especially important in a small, single-group study because readers may be tempted to treat an observed change as an intervention effect or to read an unreported result as a negative finding. Neither interpretation is justified.

The registry record makes clear that the primary outcome data are withheld for privacy and confidentiality and that only 1 participant was randomized. This sharply limits what can be learned from the public record about the endpoint. Without a numerical estimate, a measure of precision, and a described analysis, readers cannot assess the size or stability of any change. The record’s enrollment entry and its statement about randomization should not be conflated into an outcome denominator.

The single-group classification also matters. A within-group measure of weight loss, if reported, would not supply a controlled estimate of what ESG changed relative to another approach. The same caution applies to safety outcomes: zero affected alongside zero at risk does not support a population-level inference about event risk.

These limitations are not reasons to assign a result in either direction. They illustrate why design, reporting, and uncertainty are integral to statistical interpretation. The registry does identify the endpoint and secondary outcome areas, which helps clarify what the study is intended to examine. But the posted information supports a description of the research question, not a conclusion about the intervention’s results.

13. 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 central limitation for interpretation is that the registry does not report the primary outcome value. The record attributes this to the low enrollment number and participant privacy and confidentiality, and states that only 1 participant was randomized. Without the result, its variability, or an interval estimate, the magnitude and precision of percent total body weight loss cannot be evaluated.

The study is classified as single-group, with allocation listed as NA and masking as none. No comparator is described, so comparative effects cannot be estimated from the registry record. A single-group design also leaves changes over time open to influences other than the intervention. The record does not report enough detail to assess how such influences were addressed.

Although enrollment is listed as 2, the primary outcome description states that only 1 participant was randomized. The record does not explain the relationship between these entries. They should not be reconciled by assumption or used to derive an outcome denominator.

The adverse-event entries list zero at risk and zero affected, which do not support an interpretable safety estimate. The registry lists secondary outcomes but does not provide their results in the record described. It also lists zero analyses and does not report an analysis plan, missing-data procedures, analysis populations, or a sample-size justification for the trial. These omissions limit evaluation of methods and results; they do not establish that particular methods were or were not used outside the registry record.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis — NCT05739162.
• Registry record last updated 2026-08-06; status last verified 2026-07.
• Results first posted 2026-08-06.
• 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.

17. Record Summary

NCT05739162 is a single-group study of Endoscopic Sleeve Gastroplasty for obesity in ulcerative colitis among people undergoing colectomy with eventual IPAA. The intervention description includes ESG followed by a lifestyle intervention after a 6-week transitional diet. The primary outcome is percent total body weight loss at 6 months.

The registry lists enrollment as 2 and states in the primary outcome description that only 1 participant was randomized. It does not report primary outcome data, citing participant privacy and confidentiality. The record lists secondary outcomes concerning peri-operative complications, gastrointestinal symptoms, pouchitis disease activity, and durable weight loss, but provides no usable results for interpreting them. Its adverse-event entries list zero at risk and zero affected, and it records zero analyses. The record identifies the study’s question and selected design features, but does not support conclusions about outcome magnitude, precision, comparative effects, or safety.