Hemorrhoids and Metalloproteinases, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 主要终点
- MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with hemorrhoids of both sex
排除标准
- •Patients with cancer
- •Hepatic failure
- •Infectious or autoimmune diseases
- •Arthritis
- •Arterial aneurysms
- •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.
结局指标
主要结局
MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids
时间窗: 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
次要结局
未报告次要终点
研究者
Prof. Raffaele Serra, MD, Ph.D.
Prof. Raffaele Serra
University of Catanzaro