Hemorrhoid BleedingNILOSNCT07295886
Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
An observational study of Hemorrhoid Bleeding and Hemorrhoids Prolapse, run by Cardarelli Hospital at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is: Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease?… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoid Bleeding, Hemorrhoids Prolapse, Hemorrhoid Pain
- What is being tested?
- topical nifedipine 0.3% plus lidocaine 1.5%
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2025to 2 May 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria
Who may be able to join
- Male and female patients aged 18-75 years.
- Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion.
- Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.
- Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).
- Ability to understand the informed consent.
- Signed informed consent.
Who cannot join
- Acute hemorrhoidal disease complicated by thrombosis or strangulation.
- Coagulopathies.
- Active neoplastic disease.
- Treatment with anticoagulants and/or chemotherapeutic agents.
- Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.
- Severe hypotensive states or cardiovascular insufficiency.
- Pregnancy or breastfeeding.
- Participation in clinical trials involving investigational drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera "Antonio Cardarelli", Napoli
Naples, 80131
Carmine Antropoli, MD, +393351221378, carmine.antropoli@aocardarelli.it
About this study
Official title: Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease
The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is:
Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.
Read the detailed description
Prospective, observational, single-center study involving the administration of topical nifedipine 0.3% plus lidocaine 1.5%, rectally and perianally twice daily for at least 21 days, in patients with uncomplicated hemorrhoidal disease.
The Primary Objective is to evaluate the real-world effectiveness of topical nifedipine 0.3% + lidocaine 1.5% in acute, uncomplicated hemorrhoidal disease, with particular focus on symptom resolution, assessed through the analysis of changes in the HDSS (Hemorrhoidal Disease Symptom Score) questionnaire. The Secondary Objectives include the assessment of topical combinations effect on reduction of hemorrhoidal prolapse (down-staging), its impact on patients' quality of life and its role in preventing hemorrhoidal thrombosis.
Eligible patients-those who meet inclusion/exclusion criteria, sign informed consent, and receive a clinically indicated therapeutic protocol within 5 days of baseline evaluation (dietary recommendations, hydration, and topical therapy)-will undergo 4 assessments over approximately 30 days:
T0: Baseline visit within 5 days of starting nifedipine 0.3% + lidocaine 1.5% T1: Telephone contact at day 10 T2: In-person visit at day 21 T3: Telephone contact at day 30
The study includes an enrollment period of 10 months, an observation period of ~30 days and total duration of ~12 months
Data will be collected at the study center and entered by the investigator or designated personnel into a web-based electronic database (e-CRF), structured according to the study flow-chart.
The study plans to enroll 80 patients. This number is justified by the expected change in HDSS score between baseline (T-1) and T2 (day 21). Assuming a standard deviation of ~5 points, a sample of 70 patients ensures a precision of 1.2 points for 95% confidence intervals. To account for a 10% drop-out rate, the final sample size is set at 80 patients.
Continuous variables will be described using mean ± SD, quartiles (25%, 50%, 75%), and min/max.
Categorical variables using absolute frequencies and percentages. Statistical analysis will be performed using SAS 9.4.
- Conditions
- Hemorrhoid Bleeding, Hemorrhoids Prolapse, Hemorrhoid Pain, Hemorrhoid, Topical Administration
- Being tested
- topical nifedipine 0.3% plus lidocaine 1.5%
- Keywords
- nifedipine 0.3% plus lidocaine 1.5%, uncomplicated hemorrhoidal disease, hemorrhoids symptoms
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical nifedipine 0.3% plus lidocaine 1.5%Drug
Transrectal and perianal application of nifedipine 0.3% plus lidocaine 1.5% cream twice daily for at least 21 days in patients with acute, uncomplicated hemorrhoidal disease
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute, uncomplicated hemorrhoidal disease | 80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria. Receives: Drug: topical nifedipine 0.3% plus lidocaine 1.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HDSS (hemorrhoidal disease symptom score) questionnaire, analyzed using paired t-test or Wilcoxon signed-rank test according to data distribution. The total HDSS ranges from 0 to 20, with higher scores indicating greater symptom severity.
Measured: From enrollment to the 30-day follow-up
Secondary outcomes (3)
Quality of life related to hemorrhoidal disease
Change in SHS-HD (Short Health Scale for Hemorrhoidal Diseases score) analyzed using paired t-test or Wilcoxon signed-rank test, depending on data distribution. Total SHS-HD score ranges from 0 to 28, with higher scores indicating greater symptom severity
Measured: From baseline to 30 day follow-up
Hemorroidal Pain
Change in VAS (Visual analogue scale) score (assessed with paired t-test or Wilcoxon test). Total VAS score ranges from 0 to 10 with higher score indicating great symptom severity.
Measured: From baseline to 30 day follow-up
Hemorrhoidal prolapse down-staging
Evaluation of Prolapse down-staging with Cochran-Armitage test for ordinal data. Prolapse grading is evaluated by Goligher scale which ranges from grade I to grade IV, with increasing severity. Particularly, grade 1: Hemorrhoids that bleed but do not prolapse; Grade 2: Hemorrhoids that prolapse but spontaneously reduce; Grade 3: Hemorrhoids that prolapse but have to be manually reduced; Grade 4: Hemorrhoids that prolapse but cannot be reduced
Measured: From baseline to 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start2 Sep 2025
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoid BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neopharmed Gentili S.p.A.
- Responsible party
- Principal investigator, Antonio Brillantino, Cardarelli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295886
- Sponsor's protocol ID
- Nilos
- Acronym
- NILOS
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. 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. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
PubMed 30451751Brillantino A, Renzi A, Talento P, Brusciano L, Marano L, Grillo M, Maglio MN, Foroni F, Palumbo A, Sotelo MLS, Vicenzo L, Lanza M, Frezza G, Antropoli M, Gambardella C, Monaco L, Ferrante I, Izzo D, Giordano A, Pinto M, Fantini C, Gasparrini M, Schiano Di Visconte M, Milazzo F, Ferreri G, Braini A, Cocozza U, Pezzatini M, Gianfreda V, Di Leo A, Landolfi V, Favetta U, Agradi S, Marino G, Varriale M, Mongardini M, Pagano CEFA, Contul RB, Gallese N, Ucchino G, D'Ambra M, Rizzato R, Sarzo G, Masci B, Da Pozzo F, Ascanelli S, Liguori P, Pezzolla A, Iacobellis F, Boriani E, Cudazzo E, Babic F, Geremia C, Bussotti A, Cicconi M, Sarno AD, Mongardini FM, Brescia A, Lenisa L, Mistrangelo M, Zuin M, Mozzon M, Chiriatti AP, Bottino V, Ferronetti A, Rispoli C, Carbone L, Calabro G, Tirro A, de Vito D, Ioia G, Lamanna GL, Asciore L, Greco E, Bianchi P, D'Oriano G, Stazi A, Antonacci N, Renzo RMD, Poto GE, Ferulano GP, Longo A, Docimo L. The Italian Unitary Society of Colon-Proctology (Societa Italiana Unitaria di Colonproctologia) guidelines for the management of acute and chronic hemorrhoidal disease. Ann Coloproctol. 2024 Aug;40(4):287-320. doi: 10.3393/ac.2023.00871.0124. Epub 2024 Aug 30.
PubMed 39228195Tarasconi A, Perrone G, Davies J, Coimbra R, Moore E, Azzaroli F, Abongwa H, De Simone B, Gallo G, Rossi G, Abu-Zidan F, Agnoletti V, de'Angelis G, de'Angelis N, Ansaloni L, Baiocchi GL, Carcoforo P, Ceresoli M, Chichom-Mefire A, Di Saverio S, Gaiani F, Giuffrida M, Hecker A, Inaba K, Kelly M, Kirkpatrick A, Kluger Y, Leppaniemi A, Litvin A, Ordonez C, Pattonieri V, Peitzman A, Pikoulis M, Sakakushev B, Sartelli M, Shelat V, Tan E, Testini M, Velmahos G, Wani I, Weber D, Biffl W, Coccolini F, Catena F. Anorectal emergencies: WSES-AAST guidelines. World J Emerg Surg. 2021 Sep 16;16(1):48. doi: 10.1186/s13017-021-00384-x.
PubMed 34530908Antropoli C, Perrotti P, Rubino M, Martino A, De Stefano G, Migliore G, Antropoli M, Piazza P. Nifedipine for local use in conservative treatment of anal fissures: preliminary results of a multicenter study. Dis Colon Rectum. 1999 Aug;42(8):1011-5. doi: 10.1007/BF02236693.
PubMed 10458123Perrotti P, Bove A, Antropoli C, Molino D, Antropoli M, Balzano A, De Stefano G, Attena F. Topical nifedipine with lidocaine ointment vs. active control for treatment of chronic anal fissure: results of a prospective, randomized, double-blind study. Dis Colon Rectum. 2002 Nov;45(11):1468-75. doi: 10.1007/s10350-004-6452-1.
PubMed 12432293Perrotti P, Antropoli C, Molino D, De Stefano G, Antropoli M. Conservative treatment of acute thrombosed external hemorrhoids with topical nifedipine. Dis Colon Rectum. 2001 Mar;44(3):405-9. doi: 10.1007/BF02234741.
PubMed 11289288Thomson WH. The nature of haemorrhoids. Br J Surg. 1975 Jul;62(7):542-52. doi: 10.1002/bjs.1800620710.
PubMed 1174785GASS OC, ADAMS J. Hemorrhoids; etiology and pathology. Am J Surg. 1950 Jan;79(1):40-3. doi: 10.1016/0002-9610(50)90189-9. No abstract available.
PubMed 15399351
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT07295886
- Acronym / sponsor ID
- NILOS / Nilos
- Conditions
- Hemorrhoid Bleeding, Hemorrhoids Prolapse, Hemorrhoid Pain, Hemorrhoid, Topical Administration
- Keywords
- nifedipine 0.3% plus lidocaine 1.5%, uncomplicated hemorrhoidal disease, hemorrhoids symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Collaborators
- Neopharmed Gentili S.p.A.
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is:
Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.
Detailed description
Prospective, observational, single-center study involving the administration of topical nifedipine 0.3% plus lidocaine 1.5%, rectally and perianally twice daily for at least 21 days, in patients with uncomplicated hemorrhoidal disease.
The Primary Objective is to evaluate the real-world effectiveness of topical nifedipine 0.3% + lidocaine 1.5% in acute, uncomplicated hemorrhoidal disease, with particular focus on symptom resolution, assessed through the analysis of changes in the HDSS (Hemorrhoidal Disease Symptom Score) questionnaire. The Secondary Objectives include the assessment of topical combinations effect on reduction of hemorrhoidal prolapse (down-staging), its impact on patients' quality of life and its role in preventing hemorrhoidal thrombosis.
Eligible patients-those who meet inclusion/exclusion criteria, sign informed consent, and receive a clinically indicated therapeutic protocol within 5 days of baseline evaluation (dietary recommendations, hydration, and topical therapy)-will undergo 4 assessments over approximately 30 days:
T0: Baseline visit within 5 days of starting nifedipine 0.3% + lidocaine 1.5% T1: Telephone contact at day 10 T2: In-person visit at day 21 T3: Telephone contact at day 30
The study includes an enrollment period of 10 months, an observation period of ~30 days and total duration of ~12 months
Data will be collected at the study center and entered by the investigator or designated personnel into a web-based electronic database (e-CRF), structured according to the study flow-chart.
The study plans to enroll 80 patients. This number is justified by the expected change in HDSS score between baseline (T-1) and T2 (day 21). Assuming a standard deviation of ~5 points, a sample of 70 patients ensures a precision of 1.2 points for 95% confidence intervals. To account for a 10% drop-out rate, the final sample size is set at 80 patients.
Continuous variables will be described using mean ± SD, quartiles (25%, 50%, 75%), and min/max.
Categorical variables using absolute frequencies and percentages. Statistical analysis will be performed using SAS 9.4.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute, uncomplicated hemorrhoidal disease | – | Drug: topical nifedipine 0.3% plus lidocaine 1.5%80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria
Key inclusion criteria (6 listed)
- Male and female patients aged 18-75 years.
- Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion.
- Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.
- Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).
- Ability to understand the informed consent.
Key exclusion criteria (8 listed)
- Acute hemorrhoidal disease complicated by thrombosis or strangulation.
- Coagulopathies.
- Active neoplastic disease.
- Treatment with anticoagulants and/or chemotherapeutic agents.
- Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical nifedipine 0.3% plus lidocaine 1.5%Transrectal and perianal application of nifedipine 0.3% plus lidocaine 1.5% cream twice daily for at least 21 days in patients with acute, uncomplicated hemorrhoidal disease | Drug | Patients with acute, uncomplicated hemorrhoidal disease |
Primary outcome
Change in HDSS (hemorrhoidal disease symptom score) questionnaire, analyzed using paired t-test or Wilcoxon signed-rank test according to data distribution. The total HDSS ranges from 0 to 20, with higher scores indicating greater symptom severity.
Time frame: From enrollment to the 30-day follow-up
3 secondary outcomes
Quality of life related to hemorrhoidal disease
Time frame: From baseline to 30 day follow-up
Hemorroidal Pain
Time frame: From baseline to 30 day follow-up
Hemorrhoidal prolapse down-staging
Time frame: From baseline to 30 day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 30451751Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. 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. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
- Results publication: PubMed 39228195Brillantino A, Renzi A, Talento P, Brusciano L, Marano L, Grillo M, Maglio MN, Foroni F, Palumbo A, Sotelo MLS, Vicenzo L, Lanza M, Frezza G, Antropoli M, Gambardella C, Monaco L, Ferrante I, Izzo D, Giordano A, Pinto M, Fantini C, Gasparrini M, Schiano Di Visconte M, Milazzo F, Ferreri G, Braini A, Cocozza U, Pezzatini M, Gianfreda V, Di Leo A, Landolfi V, Favetta U, Agradi S, Marino G, Varriale M, Mongardini M, Pagano CEFA, Contul RB, Gallese N, Ucchino G, D'Ambra M, Rizzato R, Sarzo G, Masci B, Da Pozzo F, Ascanelli S, Liguori P, Pezzolla A, Iacobellis F, Boriani E, Cudazzo E, Babic F, Geremia C, Bussotti A, Cicconi M, Sarno AD, Mongardini FM, Brescia A, Lenisa L, Mistrangelo M, Zuin M, Mozzon M, Chiriatti AP, Bottino V, Ferronetti A, Rispoli C, Carbone L, Calabro G, Tirro A, de Vito D, Ioia G, Lamanna GL, Asciore L, Greco E, Bianchi P, D'Oriano G, Stazi A, Antonacci N, Renzo RMD, Poto GE, Ferulano GP, Longo A, Docimo L. The Italian Unitary Society of Colon-Proctology (Societa Italiana Unitaria di Colonproctologia) guidelines for the management of acute and chronic hemorrhoidal disease. Ann Coloproctol. 2024 Aug;40(4):287-320. doi: 10.3393/ac.2023.00871.0124. Epub 2024 Aug 30.
- Results publication: PubMed 34530908Tarasconi A, Perrone G, Davies J, Coimbra R, Moore E, Azzaroli F, Abongwa H, De Simone B, Gallo G, Rossi G, Abu-Zidan F, Agnoletti V, de'Angelis G, de'Angelis N, Ansaloni L, Baiocchi GL, Carcoforo P, Ceresoli M, Chichom-Mefire A, Di Saverio S, Gaiani F, Giuffrida M, Hecker A, Inaba K, Kelly M, Kirkpatrick A, Kluger Y, Leppaniemi A, Litvin A, Ordonez C, Pattonieri V, Peitzman A, Pikoulis M, Sakakushev B, Sartelli M, Shelat V, Tan E, Testini M, Velmahos G, Wani I, Weber D, Biffl W, Coccolini F, Catena F. Anorectal emergencies: WSES-AAST guidelines. World J Emerg Surg. 2021 Sep 16;16(1):48. doi: 10.1186/s13017-021-00384-x.
- Results publication: PubMed 10458123Antropoli C, Perrotti P, Rubino M, Martino A, De Stefano G, Migliore G, Antropoli M, Piazza P. Nifedipine for local use in conservative treatment of anal fissures: preliminary results of a multicenter study. Dis Colon Rectum. 1999 Aug;42(8):1011-5. doi: 10.1007/BF02236693.
- Results publication: PubMed 12432293Perrotti P, Bove A, Antropoli C, Molino D, Antropoli M, Balzano A, De Stefano G, Attena F. Topical nifedipine with lidocaine ointment vs. active control for treatment of chronic anal fissure: results of a prospective, randomized, double-blind study. Dis Colon Rectum. 2002 Nov;45(11):1468-75. doi: 10.1007/s10350-004-6452-1.
- Results publication: PubMed 11289288Perrotti P, Antropoli C, Molino D, De Stefano G, Antropoli M. Conservative treatment of acute thrombosed external hemorrhoids with topical nifedipine. Dis Colon Rectum. 2001 Mar;44(3):405-9. doi: 10.1007/BF02234741.
- Results publication: PubMed 1174785Thomson WH. The nature of haemorrhoids. Br J Surg. 1975 Jul;62(7):542-52. doi: 10.1002/bjs.1800620710.
- Results publication: PubMed 15399351GASS OC, ADAMS J. Hemorrhoids; etiology and pathology. Am J Surg. 1950 Jan;79(1):40-3. doi: 10.1016/0002-9610(50)90189-9. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoid Bleeding and Hemorrhoids Prolapse, run by Cardarelli Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Brillantino, MD, PhD (+393290119127, antonio.brillantino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HDSS (hemorrhoidal disease symptom score) questionnaire, analyzed using paired t-test or Wilcoxon signed-rank test according to data distribution. The total HDSS ranges from 0 to 20, with higher scores indicating greater symptom severity. (time frame: From enrollment to the 30-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07295886, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.