Hemorrhoids and Metalloproteinases, Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

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.

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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.

Conditions

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HEMORRHOIDS Extracellular Matrix Alteration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group I

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.

Group Type EXPERIMENTAL

Hemorrhoidectomy

Intervention Type PROCEDURE

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 sampling

Intervention Type OTHER

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

tissue sampling

Intervention Type OTHER

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

Group II

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

Group Type EXPERIMENTAL

blood sampling

Intervention Type OTHER

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

Interventions

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Hemorrhoidectomy

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

Intervention Type PROCEDURE

blood sampling

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

Intervention Type OTHER

tissue sampling

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes