The Immunological Differences Between Fournier Gangrene and Perianal Abscess

September 7, 2023 updated by: Ufuk Oguz Idiz, Istanbul Training and Research Hospital

The Cytokines and Immune Checkpoint Differences Between Fournier Gangrene and Perianal Abscess

Although it is rarely observed, necrotizing fasciitis progresses with high mortality and serious complications. Fournier's gangrene is a specific form of necrotizing fasciitis. In laboratory tests, leukocytosis or leukopenia, anemia, lymphopenia can be observed. Perianal abscess is a surgical emergency that is observed much more frequently than necrotizing fasciitis. Although Fournier's gangrene has many different etiologies, it rarely occurs due to the progression of perianal abscess, and although it is difficult to distinguish between these two diseases at diagnosis, the two diseases manifest themselves as different entities. In this study, blood cytokine levels will be evaluated in patients with Fournier's gangrene and perianal abscess, and the role of blood cytokine levels in the differential diagnosis of these two diseases will be investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although it is rarely observed, necrotizing fasciitis progresses with high mortality and serious complications. Fournier's gangrene is a specific form of necrotizing fasciitis and is located in the external genital organs and perianal region, causing thrombosis in the arteries feeding this region, gangrene in the skin and subcutaneous tissues, sepsis, and multiorgan failure.

The prognosis of Fournier's gangrene is closely related to the time of initiation of treatment. In cases where treatment is delayed, high mortality can be observed due to septic shock and related complications.

In laboratory tests, leukocytosis or leukopenia, anemia, and lymphopenia can be observed. In a study evaluating conditions that increase mortality with soft tissue necrosis, it was reported that high body mass index, abnormal leukocytes, CRP and platelet values were proportional to the severity of the disease.

Perianal abscess is a surgical emergency that is observed much more frequently than necrotizing fasciitis. Patients usually present with an erythematous swelling near the anus and hesitate to be examined. About 90% of idiopathic perianal abscesses occur due to infection of the cryptoglandular glands.

Although Fournier's gangrene has many different etiologies, it rarely occurs due to the progression of perianal abscess, and although it is difficult to distinguish between these two diseases in the diagnosis, the two diseases manifest themselves as different entities. In a study, higher IL17 levels were found in perianal abscess patients compared to the control group. Apart from this, we did not find any study on blood cytokine levels in patients with perianal abscess or Fournier's gangrene in our literature review.

In this study, blood cytokine levels will be evaluated in patients with Fournier's gangrene and perianal abscess, and the role of blood cytokine levels in the differential diagnosis of these two diseases will be investigated.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Gaziosmanpasa Training and Research Hospital
      • Istanbul, Turkey
        • Seyrantepe Hamidiye Etfal Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

In this study, patients who applied to the emergency department with rectal pain and were diagnosed with perianal abscess or Fournier's gangrene and volunteers in the same age range without any disease will be included.

Description

Inclusion Criteria:

  • Patients applying to the emergency department with Fournier's gangrene and perianal abscess.

Exclusion Criteria:

  • Patients with primary immunodeficiency
  • Crohn's patients
  • HIV patients,
  • Cancer patients,
  • Pregnancy,
  • Patients younger than 18 years and older than 88 years
  • Patients who did not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy volunteers with no known chronic or cancer disease
Diagnostic test: Cytokine levels
Preoperative cytokine levels of the patients
Fournier's gangrene
Fournier's gangrene patients
Diagnostic test: Cytokine levels
Preoperative cytokine levels of the patients
Perianal abscess
Perianal abscess patients
Diagnostic test: Cytokine levels
Preoperative cytokine levels of the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokines
Time Frame: 1 day
Values in pg/ml of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

September 3, 2022

First Submitted That Met QC Criteria

September 3, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fournier Gangrene

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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