Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade

NCT07376928•Italfarmaco

Summary

Hemorrhoidal disease is one of the most common proctologic disease. This condition affects a large number of people in the world: the prevalence can vary from 4.4% in the general population to 36.4% in general practice \[1\]. It usually appears with symptoms and signs of bleeding, prolapse, soiling, itching, and pain. Bleeding is the most relevant and frequent symptom, reported by 56-81% of the patients; this sign is the most important reason for which most of patients are worried and they decide to be subjected to proctologic examination. Medical and conservative management (life style changes, high-fiber diets, stool softeners, laxatives, and sitz baths are treatments chosen in hemorrhoidal disease from Goligher's I to III grade. Hemorrhoidal disease (HD) has a significative incidence accounting for a large number of consultation per year and a large number of ambulatory or surgical treatments. Early symptoms are often treated tempirically with self prescription and OTC (over-the-counter) products with in spite of the value of different substances available. In addition, symptoms such as tenesmus, mucus secretion or intense anal pain, if frequent and intense, significantly worsen the patient's quality of life and therefore require particular attention Phlebotonics are heterogeneous and widely investigated classes of drugs used to treat hemorrhoidal disease, with the aim to obtain strengthening of blood vessel walls, increasing venous tone, lymphatic drainage, normalizing capillary permeability, and anti-inflammatory effects. Scientific production includes research on individual active ingredients but also on products that exploit the synergy of multiple active ingredients. Furthermore, the use of flavonoids is being analyzed both as an alternative to surgery, both in preparation and after the surgery itself.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Capable of giving signed informed consent allowing data collection in accordance with local requirements;
•Males or females aged ≥ 18 years;
•Patients with symptomatic hemorrhoidal disease (HD) of I, II or III Goligher grade;
•Patients who are going to start treatment with phlebotonics, according to the clinical practice and according to the approved indications as described in the current version of the SmPC (Summary of Product Characteristics) approved in Italy. Patients are considered includible both in case never used phlebotonics or have stopped using phlebotonics for at least one month.

Exclusion Criteria

•Presence of concomitant, severe systemic disorders;
•Hypersensitivity to the active ingredients of products under observation, or to one or more excipients present in the products under observation or known hypersensitivity to any other product containing the same active ingredients or excipients;
•History of Colorectal or anal cancer and/or radiotherapy; obstructive defecation syndrome; irritable bowel syndrome; inflammatory bowel disease; coagulation disorders; other proctologic diseases, such as anal abscess or fistula; anal fissure or acute hemorrhoidal thrombosis; and anticoagulant or anti-aggregant intake for another disease;
•Women who are known to be pregnant or breastfeeding;
•Current participation in another trial is not permitted unless it is a non-interventional study, and the sole purpose of the trial is for long-term follow up describing clinical features or survival data (registry).

Locations (1)

Ospedale Piero Palagi

Florence, Italy

Key Dates

Start Date

April 5, 2023

Primary Completion Date

January 28, 2025

Completion Date

January 28, 2025

Last Updated

January 29, 2026

Enrollment

131

ACTUAL participants

Conditions

Hemorrhoidal Disease

Interventions

Phlebotonic

DRUG

Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After HAL Doppler or HAL-RAR Intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade

Inclusion Criteria

Exclusion Criteria

Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After HAL Doppler or HAL-RAR Intervention

A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy

Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial

Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease

Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment