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
About this trial
This is an interventional basic science trial for HEMORRHOIDS focused on measuring Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases
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.
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
NCT ID
NCT02358174
First Posted
January 22, 2015
Last Updated
February 3, 2015
Sponsor
University of Catanzaro
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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