Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorCardarelli Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Acute hemorrhoidal disease complicated by thrombosis or strangulation.
Coagulopathies.
Active neoplastic disease.
Treatment with anticoagulants and/or chemotherapeutic agents.
Trial population
The study will include 80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
topical nifedipine 0.3% plus lidocaine 1.5%
DrugTransrectal 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
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Patients with acute, uncomplicated hemorrhoidal disease1 intervention
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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-up2
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-up3
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cardarelli Hospital
Lead sponsor
Neopharmed Gentili S.p.A.
Collaborator
Source ClinicalTrials.gov