NCT02358174

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

January 22, 2015

Last Update Submit

February 3, 2015

Conditions

HEMORRHOIDSExtracellular Matrix Alteration

Keywords

HemorrhoidsMMPNGALMatrix Metalloproteinases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Procedure: HemorrhoidectomyOther: blood samplingOther: tissue sampling

Group II

EXPERIMENTAL

Healthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling.

Other: blood sampling

Interventions

HemorrhoidectomyPROCEDURE

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

Group I
blood samplingOTHER

blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)

Group IGroup II
tissue samplingOTHER

tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)

Group I

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hemorrhoids of both sex

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26263832DERIVED

MeSH Terms

Conditions

Hemorrhoids

Interventions

HemorrhoidectomyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Raffaele Serra

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 6, 2015

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 6, 2015

Record last verified: 2015-02