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OpenTrials
Completed

NCT Number: NCT02358174

Hemorrhoids and Metalloproteinases, Observational Study

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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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Extracellular Matrix Alteration Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemorrhoidectomy

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

Other

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

Tissue Sampling

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Acronym: HeMe

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2015
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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