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Hemorrhoids and Metalloproteinases, Observational Study (HeMe)

Primary Purpose

HEMORRHOIDS, Extracellular Matrix Alteration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hemorrhoidectomy
blood sampling
tissue sampling
Sponsored by
University of Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HEMORRHOIDS focused on measuring Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group I

    Group II

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 22, 2015
    Last Updated
    February 3, 2015
    Sponsor
    University of Catanzaro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02358174
    Brief Title
    Hemorrhoids and Metalloproteinases, Observational Study
    Acronym
    HeMe
    Official Title
    Hemorrhoids and Metalloproteinases, Observational Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Catanzaro

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HEMORRHOIDS, Extracellular Matrix Alteration
    Keywords
    Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    187 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group II
    Arm Type
    Experimental
    Arm Description
    Healthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hemorrhoidectomy
    Intervention Description
    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
    Other
    Intervention Name(s)
    blood sampling
    Intervention Description
    blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)
    Intervention Type
    Other
    Intervention Name(s)
    tissue sampling
    Intervention Description
    tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)
    Primary Outcome Measure Information:
    Title
    MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids
    Description
    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
    Time Frame
    15 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26263832
    Citation
    Serra R, Gallelli L, Grande R, Amato B, De Caridi G, Sammarco G, Ferrari F, Butrico L, Gallo G, Rizzuto A, de Franciscis S, Sacco R. Hemorrhoids and matrix metalloproteinases: A multicenter study on the predictive role of biomarkers. Surgery. 2016 Feb;159(2):487-94. doi: 10.1016/j.surg.2015.07.003. Epub 2015 Aug 8.
    Results Reference
    derived

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    Hemorrhoids and Metalloproteinases, Observational Study

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