Hemorrhoids and Metalloproteinases, Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hemorrhoids and Metalloproteinases, Observational Study

Conditions
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HEMORRHOIDS, Extracellular Matrix Alteration

Intervention / Treatment
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* Procedure: Hemorrhoidectomy
* Other: blood sampling
* Other: tissue sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>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. | Procedure: Hemorrhoidectomy<br>* 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<br>Other: blood sampling<br>* blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)<br>Other: tissue sampling<br>* tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)<br>|
| Experimental: Group II<br>Healthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling. | Other: blood sampling<br>* blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases