Hemorrhoids and Metalloproteinases, Observational Study (HeMe)

February 3, 2015 updated by: Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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

Other: blood sampling
blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)
Other: tissue sampling
tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)
Experimental: Group II
Healthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling.
Other: blood sampling
blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids
Time Frame: 15 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ER.ALL.2013.27.A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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