Hemorrhoids and Metalloproteinases, Observational Study

University of Catanzaro187 enrolled

Overview

An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and different stages hemorrhoids. The study provides potentially important insights to the understanding of the natural history of Hemorrhoids and MMPs and NGAL regulation.

Introduction. An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and different stages hemorrhoids. Methods. In a multicenter, open-label, prospective study, patients with hemorrhoids were recruited and represented the Group I (patients with symptomatic hemorrhoids - Grade I to IV sec. Goligher), a further group of healthy volunteer subjects were also recruited as the control group (Group II). Enzyme-linked immunosorbent assay and Western blot analysis will evaluate the levels of immunoreactive MMPs and NGAL in all patients with hemorrhoids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

187

Conditions

HEMORRHOIDS Extracellular Matrix Alteration

Interventions

HemorrhoidectomyPROCEDURE

Grade III and IV patients were treated with surgery according to Milligan-Morgan (Milligan-Morgan laser optical fibers variant) procedure. All patients will perform blood sampling for MMPs and NGAL plasma levels evaluation

blood samplingOTHER

blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)

tissue samplingOTHER

tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with hemorrhoids of both sex Exclusion Criteria: * Patients with cancer * Hepatic failure * Infectious or autoimmune diseases * Arthritis * Arterial aneurysms * Hernias * Chronic venous disease * Nephritis, vascular ulcers, fibrosis, and other diseases associated with increased levels of MMPs were excluded from the study. * Patients treated with corticosteroids or cytostatic drugs were also excluded.

Outcomes

Primary Outcomes

MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids

A new insight in the understanding of the natural history of. MMPs and NGAL play a role in development of disease and may represent molecular markers for the prevention of hemorrhoidal thrombosis. Unit of Measure: MMPs and NGAL plasma levels will be expressed as ng/mL. Tissue expression of MMPs and NGAL will be expressed as Arbitrary Units

Time frame: 15 months

Data from ClinicalTrials.gov

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