The Immunological Differences Between Fournier Gangrene and Perianal Abscess

Perianal Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529628
• Other study ID #: Fournier Gangrene
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2023
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Fournier Gangrene
• Gangrene
• Perianal Abscess

Intervention

Diagnostic Test:
• Cytokine levels
Preoperative cytokine levels of the patients

Locations

Country	Name	City	State
Turkey	Istanbul Gaziosmanpasa Training and Research Hospital	Istanbul
Turkey	Seyrantepe Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Diab J, Bannan A, Pollitt T. Necrotising fasciitis. BMJ. 2020 Apr 27;369:m1428. doi: 10.1136/bmj.m1428. No abstract available. — View Citation

Park SJ, Kim DH, Choi CI, Yun SP, Kim JH, Seo HI, Jo HJ, Jun TY. Necrotizing soft tissue infection: analysis of the factors related to mortality in 30 cases of a single institution for 5 years. Ann Surg Treat Res. 2016 Jul;91(1):45-50. doi: 10.4174/astr.2016.91.1.45. Epub 2016 Jun 30. — View Citation

Wang JP, Cai C, Du JL, Shi HQ, Liu QW, Dai ZH, Zhong ZF. Role of interleukin-17 in the pathogenesis of perianal abscess and anal fistula: a clinical study on 50 patients with perianal abscess. ANZ J Surg. 2019 Mar;89(3):244-247. doi: 10.1111/ans.14874. Epub 2018 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines	Values in pg/ml of IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33	1 day