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Hemorrhoids and Metalloproteinases, Observational Study

Hemorrhoids and Metalloproteinases, Observational Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02358174
Acronym
HeMe
Enrollment
187
Registered
2015-02-06
Start date
2013-09-30
Completion date
2014-12-31
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracellular Matrix Alteration, HEMORRHOIDS

Keywords

Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases

Brief summary

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

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.

Interventions

PROCEDUREHemorrhoidectomy

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

OTHERblood sampling

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

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

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids15 monthsA 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026