Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease

Official title

Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease

Overview

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

• Drug 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

Primary outcome measures

• 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]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Italy · 1 center

• Azienda Ospedaliera "Antonio Cardarelli", Napoli — Naples

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. PMID 30451751
• Brillantino 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 PMID 39228195
• Tarasconi 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, Sakakus PMID 34530908
• Antropoli 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. PMID 10458123
• Perrotti 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. PMID 12432293
• Perrotti 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. PMID 11289288
• Thomson WH. The nature of haemorrhoids. Br J Surg. 1975 Jul;62(7):542-52. doi: 10.1002/bjs.1800620710. PMID 1174785
• GASS 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. PMID 15399351

Identifiers

NCT: NCT07295886 · Nilos

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗