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 Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms (NCT06420986), a randomized na study. The primary outcome is Hemorrhoidal Disease Symptom Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06420986 |
| Phase | NA |
| Condition | Hemorrhoids Third Degree |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Hospital Son Llatzer |
| Results posted | Yes |
2. Clinical Question
Population
Adults with grade III hemorrhoids are the target population described in the registry record. More detailed eligibility criteria, such as restrictions on prior treatment or other health conditions, are not reported in the registry record. The record describes surgical treatment and symptom forms completed before surgery and one year afterward.
Intervention
The intervention is open hemorrhoidectomy. The trial asks whether patients undergoing this operation have fewer hemorrhoid-related symptoms one year after surgery. The posted primary outcome is a symptom score, with higher scores indicating worse symptoms.
Comparator
The comparator is transanal hemorrhoidal dearterialization, abbreviated THD in the trial description. The study is randomized and parallel, with participants assigned to one of the two procedures. The registry record describes the trial as open-label, so masking is not used.
Primary question
At one year, how do symptom scores compare between the two procedures? The registry record reports median scores of 1 for hemorrhoidectomy and 7 for THD. Because higher scores mean worse symptoms, the observed medians favor the lower-score direction for hemorrhoidectomy. The record does not report a formal primary-outcome comparison, confidence interval, or p-value, so the size and statistical uncertainty of the between-group difference cannot be established from those medians alone.
The question concerns symptoms after surgery rather than only whether a procedure was completed or whether a complication occurred. Symptom forms were intended to capture the frequency of pain, pruritus, bleeding, soiling, and prolapse. The registry description also specifies control visits after surgery. The trial therefore frames the comparison around patient-reported symptom burden at one year, while postoperative pain and fecal incontinence are listed as secondary outcomes.
3. Trial Design
This is a randomized, parallel-group, open-label trial registered as NCT06420986. It compares open hemorrhoidectomy with transanal hemorrhoidal dearterialization in people with grade III hemorrhoids. The listed enrollment is 50. The sponsor is Hospital Son Llatzer. The registry record gives a start date of 2021-08-12, a primary completion date of 2024-04-17, and a completed status.
Participants undergo one of the two surgical procedures and complete symptom forms before surgery and one year afterward. The planned follow-up visits are one week, one month, three months, and one year after the procedure. The primary outcome is the Hemorrhoidal Disease Symptom Score at one year. The posted outcome summaries include 24 participants for hemorrhoidectomy and 23 for THD. The registry record does not explain the difference between the enrollment figure and the outcome counts, or describe participant flow and reasons for missing outcome data.
Random allocation supports a planned comparison between groups, but the open-label design means participants and clinical staff were not masked to treatment assignment. That feature matters when interpreting outcomes based on symptom reporting, since awareness of the procedure could influence reporting or assessment. The registry record does not report allocation concealment, the randomization sequence method, stratification factors, or the analysis population. It also does not report a protocol-level statistical analysis plan or a sample-size justification.
The record lists phase as not applicable. It identifies postoperative pain and fecal incontinence as secondary outcomes, although detailed posted numerical results are available for postoperative pain. Detailed fecal incontinence results are not 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 | Hemorrhoidectomy | Transanal Hemorrhoidal Dearterialization |
|---|---|---|
| STARTED | 25 | 25 |
| COMPLETED | 24 | 23 |
| NOT COMPLETED | 1 | 2 |
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 | Hemorrhoidectomy | Transanal Hemorrhoidal Dearterialization | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 25 | 50 | |
| Age, Continuous | years | 49 (SD 2) | 48 (SD 2) | 48 (SD 2) |
| Sex: Female, Male: Female | Participants | 12 | 13 | 25 |
| Sex: Female, Male: Male | Participants | 13 | 12 | 25 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Hemorrhoidal Disease Symptom Score, measured over one year.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Hemorrhoidal Disease Symptom Score measured at one year. It combines the frequency of pain, pruritus, bleeding, soiling, and prolapse into a score from 0 to 20. Higher scores indicate worse symptoms. The score is intended to represent several aspects of hemorrhoidal symptoms in one outcome, rather than treating each symptom as a separate primary question.
The registry record summarizes this endpoint using medians and inter-quartile ranges. A median describes the central position of the observed scores: half of the values are at or below it and half are at or above it, subject to ties. The inter-quartile range describes the middle half of the observed values. It is a measure of spread, not a confidence interval and not a direct measure of uncertainty about the difference between treatment groups.
At one year, the posted median is 1 with an inter-quartile range of 0 to 2 for hemorrhoidectomy, and 7 with an inter-quartile range of 2 to 9 for THD. Because lower scores indicate fewer symptoms, the observed median scores are in the lower-symptom direction for hemorrhoidectomy. These summaries do not, by themselves, show how precisely the groups differ or whether a formal statistical comparison supports a difference. A primary-outcome comparison estimate and its uncertainty are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome summaries show a median Hemorrhoidal Disease Symptom Score of 1 (inter-quartile range 0 to 2) after hemorrhoidectomy and 7 (inter-quartile range 2 to 9) after THD, at one year. The score ranges from 0 to 20, with higher values indicating worse symptoms. Thus the observed medians are in the direction of fewer reported symptoms in the hemorrhoidectomy group. The inter-quartile ranges describe the middle half of observed scores; they are not confidence intervals for the group medians or for a treatment contrast.
The registry record does not report a primary-outcome test, an estimated between-group difference, a confidence interval, or a p-value. As a result, the posted medians do not establish the precision of the comparison. They also do not show whether the apparent separation in medians reflects a consistent difference across participants or how much the distributions overlap. The outcome counts are 24 for hemorrhoidectomy and 23 for THD. The record does not explain why these counts differ from the listed enrollment or provide a missing-data account.
The secondary postoperative-pain result is reported as a mean of 5.58 (standard deviation 0.34) for hemorrhoidectomy and 3.92 (standard deviation 0.44) for THD one week after surgery. A simple unadjusted recalculation gives a mean difference of -1.66 for THD relative to hemorrhoidectomy, with a 95% confidence interval from -1.878 to -1.442 and an unadjusted p-value of <0.001. This secondary finding is in a different direction from the one-year primary symptom-score medians. These outcomes measure different things at different times, so they should not be read as contradictory estimates of the same endpoint.
The pain comparison is an unadjusted secondary analysis. The registry record does not report a sponsor analysis for this comparison, and no adjustment for multiple secondary outcomes is described. Its p-value therefore does not carry the same confirmatory weight as a prespecified, adequately reported primary analysis would. The posted summaries are descriptive evidence from this trial, not proof that either procedure produces a particular result for every patient or in other populations. The record does not report a clinically important difference threshold for the primary score, so the clinical importance of the observed median separation cannot be determined from the score summaries alone.
9. Statistical Methods Explained
The methods information in the registry record is incomplete for interpreting the primary comparison. It identifies a randomized, parallel-group trial and posts group summaries for the one-year symptom score, but it does not report a primary-outcome statistical test or an estimated treatment contrast. The record also reports no analyses for the primary outcome. Therefore the primary result can be described using the observed medians and inter-quartile ranges, but not as a formal inferential comparison.
What do the median and inter-quartile range describe?
For a skewed or ordinal outcome, the median can describe the center of the observed distribution without requiring the values to follow a symmetric bell-shaped pattern. The inter-quartile range describes the span between the first and third quartiles, which contains the middle half of the observations. These summaries are useful for seeing where typical observed values lie and how broadly they vary. They do not provide a standard error, a confidence interval for a treatment effect, or a test of whether group distributions differ.
The Hemorrhoidal Disease Symptom Score is bounded from 0 to 20 and is reported as a median. A bounded score may not behave like an unbounded continuous measurement, and a median-based summary does not reveal every feature of its distribution. A statistical comparison could target a difference in medians, a rank-based contrast, or another estimand, but the registry record does not state which method was planned or used. No method should be inferred from the fact that the score was summarized by medians.
What does the postoperative-pain comparison represent?
Postoperative pain is summarized using means and standard deviations. The posted means are 5.58 for hemorrhoidectomy and 3.92 for THD at one week after surgery. A simple unadjusted recalculation gives a mean difference of -1.66 for THD relative to hemorrhoidectomy. The negative sign indicates that the THD group mean is lower under that stated comparison direction. The recalculated 95% confidence interval is -1.878 to -1.442, and the unadjusted p-value is <0.001.
A confidence interval expresses the uncertainty associated with an estimated contrast under the assumptions of the analysis. It is not a range containing every participant's outcome, and it does not give the probability that the true effect lies in that particular interval. A p-value describes how compatible the observed data are with a specified null model, under the analysis assumptions; it does not measure clinical importance. These are unadjusted recalculations from posted summary statistics, not a reported sponsor analysis. The registry record does not describe a prespecified model, covariate adjustment, or diagnostic checks for this comparison.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, standard errors can be too small and confidence intervals too narrow, making statistical evidence appear stronger than it is. Conversely, a model that allows for more variability can produce wider uncertainty. This is a general statistical consideration, not a reported feature of this trial. The registry record does not specify a distributional model for the primary score or report an assessment of over-dispersion.
What do the sample-size illustrations mean?
The planning figures for postoperative pain are illustrations based on fractions of the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are not the trial's original design calculation and are not observed power. The listed planning rows describe 100%, 75%, and 50% of the observed effect. For 80% power, the corresponding figures are 1, 2, and 4 participants per arm; for 90% power, they are 2, 3, and 5 participants per arm. Such unusually small illustrations reflect the very large observed standardized contrast in this small dataset and the assumptions used in the calculation. They should not be treated as a reliable recommendation for a future study or as evidence that the completed trial had adequate power. The registry record does not report its own sample-size justification.
Which analysis details are unavailable?
The registry record does not report the primary hypothesis test, the planned estimand, the handling of missing outcomes, an intention-to-treat or per-protocol definition, or a method for multiple comparisons. It also does not report a primary-outcome confidence interval or p-value. These omissions limit assessment of the analysis choices and of the precision of the main comparison. Randomization describes assignment, but it does not fill in missing analysis details or guarantee that the posted outcome counts represent every randomized participant.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report how multiplicity was handled. Multiplicity arises when investigators test more than one outcome, time point, subgroup, or treatment contrast. If many tests are conducted, the chance of at least one apparently positive result can increase even when none of the underlying effects is real. Approaches such as a prespecified outcome hierarchy or an adjustment to the testing threshold can address this issue, but no such approach is described in the registry record. The unadjusted secondary pain p-value should therefore be interpreted with caution and should not substitute for a clearly reported primary analysis.
Missing-data information is also limited. The primary outcome summaries include 24 participants in the hemorrhoidectomy group and 23 in the THD group, while the listed enrollment is 50. The registry record does not state how many participants were randomized to each group, how many completed follow-up, why any outcome values were unavailable, or how missing values were handled. It does not report whether the analysis used all randomized participants, only participants with observed outcomes, or another population definition. These details matter because missingness can affect the comparability of groups after randomization, particularly if the likelihood of an unavailable score is related to symptoms or treatment.
The registry record also does not report an analysis plan, sensitivity analyses for missing data, or a comparison between different analysis populations. It gives no primary-outcome confidence interval or p-value and does not describe adjustments for baseline values or other covariates. These omissions do not establish that any particular analysis choice was made; they mean the choices are not reported in the registry record. Consequently, the primary medians are best read as descriptive summaries, and the uncertainty around the between-group comparison remains unclear.
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 |
|---|---|---|---|
| Hemorrhoidectomy | 0 | 25 | 0.0% |
| Transanal Hemorrhoidal Dearterialization | 0 | 25 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hemorrhoidectomy | 0 of 25 |
| Transanal Hemorrhoidal Dearterialization | 0 of 25 |
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 |
|---|---|
| Hemorrhoidectomy | 7 of 25 |
| Transanal Hemorrhoidal Dearterialization | 11 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Hemorrhoidectomy | Transanal Hemorrhoidal Dearterialization |
|---|---|---|---|
| Prolonged pain | Nervous system disorders | 5 of 25 | 5 of 25 |
| Bleeding | Surgical and medical procedures | 2 of 25 | 4 of 25 |
| Acute Urinary retention | Renal and urinary disorders | 0 of 25 | 2 of 25 |
| Diarrhoea | Gastrointestinal disorders | 0 of 25 | 1 of 25 |
The registry record reports zero serious adverse events in each treatment group, with 25 participants at risk in each group. It reports zero deaths in each group. For other, non-serious adverse events, the posted figures are 7 affected in the hemorrhoidectomy group and 11 affected in the THD group, with 25 at risk in each group. The record does not provide a list of the most common serious adverse-event terms.
These figures describe events recorded during the trial; they do not establish that either procedure has no serious risks. A count of zero observed serious events is not evidence that the underlying risk is zero, particularly when the number at risk is limited. The record does not give the adverse-event collection period, event definitions, severity details for the other events, or a statistical comparison. It also does not explain whether the figures represent participants with at least one event or event counts beyond the labels in the record. The groups should therefore be described using the posted counts without inferring causality or comparative safety from them alone.
12. What the Result Does, and Does Not, Mean
The posted primary summaries show lower one-year symptom-score medians for hemorrhoidectomy than for THD. Since higher scores represent worse symptoms, the observed medians favor the lower-symptom direction for hemorrhoidectomy in this trial. This is a description of the available outcome data, not a conclusion that the procedure will produce the same result for every participant or in other settings.
The record does not report a formal primary-outcome comparison or the uncertainty around a treatment contrast. The median and inter-quartile range cannot be used as a substitute for a confidence interval or hypothesis test. Nor does the record provide a threshold for what change in the score would be clinically important. As a result, the statistical precision and clinical importance of the observed primary-score separation cannot be determined from the posted summaries alone.
The secondary postoperative-pain result concerns an earlier time point and a different measure. Its direction differs from that of the primary symptom-score medians, and it is an unadjusted secondary comparison. It should not be combined with the primary result into a single overall claim. The registry record lists fecal incontinence but does not report detailed results for that outcome.
Randomization is a strength for comparing assigned groups, but it does not resolve limitations arising from open-label treatment, incomplete analysis reporting, or unexplained outcome counts. The results do not establish a mechanism, prove that the observed pattern is caused by the procedure, or answer questions about outcomes beyond those recorded. They also do not support medical advice. The appropriate reading is limited to the posted summaries and their stated measurement times.
13. Why This Trial Matters Statistically
This trial illustrates why a treatment comparison needs more than two group summaries. The primary outcome is reported as medians and inter-quartile ranges, which describe observed symptom scores but do not quantify uncertainty in a between-group contrast. Without a reported primary estimate and confidence interval, readers cannot assess how precise the apparent separation is or how compatible the data are with a range of possible differences.
It also shows how outcome choice and timing affect interpretation. The main endpoint measures several hemorrhoid-related symptoms at one year, while the reported secondary pain outcome concerns one week after surgery. Their directions differ, but they are not measuring the same clinical question. Keeping endpoint definitions and time points distinct prevents an early recovery measure from being mistaken for a long-term symptom result.
The open-label design is especially relevant when outcomes depend on symptom reporting. Randomization supports a fair planned comparison, yet masking and complete reporting of the analysis remain important to judging the evidence. The registry record does not provide several details needed for that assessment, including the primary inferential analysis, missing-data handling, and multiplicity approach.
Finally, the secondary pain recalculation and its planning illustrations show why statistical significance, effect size, and study design should not be conflated. The observed secondary contrast is large relative to its reported standard deviations, but the planning figures are based on that observed effect and are not the trial's design justification or observed power. A future study should not rely on an unusually large observed estimate without considering uncertainty and the possibility that effects are smaller. The record does not report how the original enrollment target was chosen.
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 incomplete reporting of the primary analysis. The registry record provides the one-year group medians and inter-quartile ranges but no primary treatment contrast, confidence interval, or p-value. This prevents direct evaluation of statistical uncertainty for the main trial question. The record also does not report a clinically important difference threshold for the symptom score, limiting interpretation of the practical importance of the observed summaries.
The primary outcome counts are 24 for hemorrhoidectomy and 23 for THD, while enrollment is listed as 50. Participant flow, group-specific randomized counts, reasons for missing outcomes, and missing-data methods are not reported in the registry record. No analysis population is defined. Without this information, it is not possible to assess whether the available outcome summaries preserve the randomized comparison or whether missingness could have influenced them.
The open-label design is a further limitation for symptom-based outcomes. Awareness of the procedure could influence participant reporting or clinical assessment; the record does not describe steps to reduce or evaluate that possibility. The record also does not provide baseline symptom summaries, detailed eligibility criteria, randomization procedures, allocation concealment, or the statistical analysis plan. These details are relevant to assessing comparability and risk of bias.
Secondary evidence is incomplete: postoperative pain has detailed results, but fecal incontinence results are not reported in the registry record. No multiplicity strategy is described. The serious adverse-event counts are limited to the posted figures and lack detailed event terms and a stated collection period. Finally, this is a single completed trial with listed enrollment of 50; the registry record does not establish how broadly its results apply to other patient populations or clinical settings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms — NCT06420986.
- Registry record last updated 2026-04-17; status last verified 2026-04.
- Results first posted 2026-03-31.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT06420986 is a completed, randomized, parallel-group, open-label trial sponsored by Hospital Son Llatzer. It compares open hemorrhoidectomy with transanal hemorrhoidal dearterialization for grade III hemorrhoids. Listed enrollment is 50; the record gives a start date of 2021-08-12 and a primary completion date of 2024-04-17.
The primary outcome is the Hemorrhoidal Disease Symptom Score at one year, a score from 0 to 20 in which higher values indicate worse symptoms. Posted medians are 1 (inter-quartile range 0 to 2) for hemorrhoidectomy and 7 (inter-quartile range 2 to 9) for THD. A primary statistical comparison and its uncertainty are not reported in the registry record.
Postoperative pain and fecal incontinence are listed as secondary outcomes. Detailed numerical results are available for postoperative pain; detailed fecal incontinence results are not reported in the registry record. The safety record reports zero serious adverse events and zero deaths in both groups.