NCT02358174

Hemorrhoids and Metalloproteinases, Observational Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: University of Catanzaro · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• HEMORRHOIDS
• Extracellular Matrix Alteration

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-02-06
• Last updated: 2015-02-06