HEMORRHOIDSHeMeNCT02358174
Hemorrhoids and Metalloproteinases, Observational Study
A study testing Hemorrhoidectomy, blood sampling and tissue sampling in people with HEMORRHOIDS and Extracellular Matrix Alteration, run by University of Catanzaro.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HEMORRHOIDS, Extracellular Matrix Alteration
- What is being tested?
- Hemorrhoidectomy, blood sampling and tissue sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with hemorrhoids of both sex
Who cannot join
- Patients with cancer
- Hepatic failure
- Infectious or autoimmune diseases
- Arthritis
- Arterial aneurysms
- Hernias
Show all 9Show fewer
- 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.
About this study
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.
Read the 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
- Being tested
- Hemorrhoidectomy, blood sampling, tissue sampling
- Keywords
- Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemorrhoidectomyProcedure or surgery
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
blood samplingOther
blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)
tissue samplingOther
tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Hemorrhoidectomy; Other: blood sampling; Other: 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. Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HEMORRHOIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358174
- Sponsor's protocol ID
- ER.ALL.2013.27.A
- Acronym
- HeMe
- Status last verified
- Feb 2015
- First submitted
- 22 Jan 2015
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26263832
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoids and Metalloproteinases, Observational Study
- ClinicalTrials.gov ID
- NCT02358174
- Acronym / sponsor ID
- HeMe / ER.ALL.2013.27.A
- Conditions
- HEMORRHOIDS, Extracellular Matrix Alteration
- Keywords
- Hemorrhoids, MMP, NGAL, Matrix Metalloproteinases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Hemorrhoidectomy, Other: blood sampling, Other: tissue samplingPatients 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 | Other: blood samplingHealthy subjects without hemorrhoids as control groups for MMPs and NGAL plasma evaluation will be performed by means of Blood sampling. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hemorrhoids of both sex
Key exclusion criteria (9 listed)
- Patients with cancer
- Hepatic failure
- Infectious or autoimmune diseases
- Arthritis
- Arterial aneurysms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemorrhoidectomyGrade 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 | Procedure or surgery | Group I |
| blood samplingblood sampling for MMPs and NGAL plasma levels evaluation (ELISA test) | Other | Group I, Group II |
| tissue samplingtissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot) | Other | Group I |
Primary outcome
MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Derived from this study: PubMed 26263832Serra 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidectomy, blood sampling and tissue sampling in people with HEMORRHOIDS and Extracellular Matrix Alteration, run by University of Catanzaro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.