Hemorrhoid, Hemorrhoid Bleeding, Hemorrhoid Pain, Hemorrhoids Prolapse, Topical Administration
Conditions
Keywords
nifedipine 0.3% plus lidocaine 1.5%, uncomplicated hemorrhoidal disease, hemorrhoids symptoms
Brief 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? 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.
Interventions
DRUGtopical 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
Sponsors
Neopharmed Gentili S.p.A.
Cardarelli Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | From enrollment to the 30-day follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life related to hemorrhoidal disease | From baseline to 30 day follow-up | 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 |
| Hemorroidal Pain | From baseline to 30 day follow-up | 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. |
| Hemorrhoidal prolapse down-staging | From baseline to 30 day follow-up | 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 |
Countries
Italy
Contacts
Primary ContactAntonio Brillantino, MD, PhD
Outcome results
None listed