Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with acute, uncomplicated hemorrhoidal disease
80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria.
干预措施: topical nifedipine 0.3% plus lidocaine 1.5% (Drug)
结局指标
主要结局
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.
时间窗: From enrollment to the 30-day follow-up
次要结局
- Quality of life related to hemorrhoidal disease(From baseline to 30 day follow-up)
- Hemorroidal Pain(From baseline to 30 day follow-up)
- Hemorrhoidal prolapse down-staging(From baseline to 30 day follow-up)
研究者
Antonio Brillantino
MD, PhD
Cardarelli Hospital