An observational study in Hemorrhoid Bleeding, Hemorrhoids Prolapse and Hemorrhoid Pain, sponsored by Cardarelli Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Cardarelli Hospital · Observational
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 80 is below the median of 151 across 49 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Cardarelli Hospital is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include 80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria.
Drug: topical nifedipine 0.3% plus lidocaine 1.5%
Drug page: Nifedipine
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
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
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
Time frame: 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.
Time frame: 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
Time frame: From baseline to 30 day follow-up
Plan to share: No
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