The Immunological Differences Between Fournier Gangrene and Perianal Abscess

Completed

• Conditions: Perianal Abscess; Fournier Gangrene
• Interventions: Diagnostic Test: Cytokine levels

• Registration Number: NCT05529628
• Lead Sponsor: Istanbul Training and Research Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-09-03
• Study First Submitted QC: 2022-09-03
• Study First Posted: 2022-09-07
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Cytokine levels	Healthy volunteers with no known chronic or cancer disease
Fournier's gangrene	Cytokine levels	Fournier's gangrene patients
Perianal abscess	Cytokine levels	Perianal abscess patients

Primary Outcome Measures

Name	Time	Method
Cytokines	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

Trial Locations

Locations (2)

Seyrantepe Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Istanbul Gaziosmanpasa Training and Research Hospital; 🇹🇷 Istanbul, Turkey