Hemorrhoids and Metalloproteinases, Observational Study

HEMORRHOIDS Clinical Trial

— HeMe  

Official title:

Hemorrhoids and Metalloproteinases, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358174
• Other study ID #: ER.ALL.2013.27.A
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: February 3, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University of Cantanzaro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Extracellular Matrix Alteration
• HEMORRHOIDS

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No