ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemorrhoids and Metalloproteinases, Observational Study (HeMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02358174
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Raffaele Serra, MD, Ph.D., University of Cantanzaro

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.


Condition or disease Intervention/treatment Phase
HEMORRHOIDS Extracellular Matrix Alteration Procedure: Hemorrhoidectomy Other: blood sampling Other: tissue sampling Not Applicable

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  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hemorrhoids and Metalloproteinases, Observational Study
Study Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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)




Primary Outcome Measures :
  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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Raffaele Serra, MD, Ph.D., Prof. Raffaele Serra, University of Cantanzaro
ClinicalTrials.gov Identifier: NCT02358174     History of Changes
Other Study ID Numbers: ER.ALL.2013.27.A
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015

Keywords provided by Prof. Raffaele Serra, MD, Ph.D., University of Cantanzaro:
Hemorrhoids
MMP
NGAL
Matrix Metalloproteinases

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases