Trial · NCT03791775
Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease
NCT03791775, Phase 2, Completed, Societa Italiana di Chirurgia ColoRettale
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease. Trials, record NCT03791775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03791775
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease
- NCT number
- NCT03791775
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 183 participants, actual
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Conditions
- Second-degree Hemorrhoids
- Interventions
- Polidocanol foam (Atossisclerol® 3%)
- First posted
- 2019-01-03
- Last updated
- 2021-09-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate 1 | 12 months follow-up | To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection Bleeding will be assessed using both the Hemorrhoidal Disease Symptoms Score and the Giamundo score. Rørvik HD et al (2019) Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum; 62:333-342 Giamundo et al (2018) Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol; 25:635-643 |
| Secondary | Success Rate 2 | 12 months follow-up | To establish the success rate in terms of partial or complete resolution of the symptoms Symptoms will be assessed using the Hemorrhoidal Disease Symptom Score described by Rorvik HD |
| Secondary | Number of outpatient sessions | 12 months follow-up | To evaluate the average number of outpatient sessions necessary for treatment success |
| Secondary | Rate of complications - adverse events | 6 months follow-up | To establish the rate of complications |
| Secondary | Quality of Life | 12 months follow-up | Short Health Scale HD 4 questions with 7-point Liker scale each (1 = very dissatisfied, 7 = very satisfied) Minimum = 4 Maximum = 28 |
| Secondary | To establish the average time required to reach autonomy | 12 months follow-up | We considered autonomy as the return to normal activity: it includes also the return to work apart from cases of retired patients in which we considered it as the complete return to daily activities |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers43
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03791775
GET https://conductscience.org/api/trials/v1/NCT03791775/papers?page=2