Hemorrhoids and Metalloproteinases, Observational Study (HeMe)

University of Catanzaro

Status: Completed

Conditions: HEMORRHOIDS; Extracellular Matrix Alteration

Treatments: Procedure: Hemorrhoidectomy; Other: blood sampling; Other: tissue sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02358174

ER.ALL.2013.27.A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups

Group I

Experimental group

Description:

Patients with symptomatic hemorrhoids - Grade I to IV sec. Goligher. Grade III to IV underwent Hemorrhoidectomy. Blood sampling for MMPs and NGAL plasma levels evaluation will be performed. Tissue sampling (obtained during hemorrhoidectomy) for MMPs and NGAL tissue levels evaluation will be performed in grade III-IV patients.

Treatment:

Procedure: Hemorrhoidectomy

Other: blood sampling

Other: tissue sampling

Group II

Experimental group

Description:

Healthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling.

Treatment:

Other: blood sampling