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 (VIVI2022/01)

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoidal Disease
• Intervention / Treatment: Drug: Phlebotonic

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50122
    • Ospedale Piero Palagi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic hemorrhoidal disease (HD) of I, II or III Goligher grade

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Phlebotonics	Drug: Phlebotonic; Phlebotonics treatment will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The baseline characteristics of this italian real-world cohort	The primary endpoint has been evaluated using HDSS-Hemorrhoidal disease symptoms score by Rorvik.	36 months

Collaborators and Investigators

• Sponsor: Italfarmaco

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): January 28, 2025
• Study Completion (Actual): January 28, 2025

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Goligher grade I; Goligher grade II; Goligher grade III
• Other Study ID Numbers: VIVI2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No