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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | 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. |
|
| Group II | Experimental | Healthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemorrhoidectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26263832 | Derived | 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. |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D061865 | Hemorrhoidectomy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
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| blood sampling | Other | blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test) |
|
| tissue sampling | Other | tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot) |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D008919 | Investigative Techniques |