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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04983056
Other study ID # FZBKSMP35
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date July 2, 2021

Study information

Verified date July 2021
Source Centre Hospitalier Universitaire Ibn Rochd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Case series with retrospective data collection of patients treated for Fournier's gangrene between January 2010 and March 2017. The main etiologies, risk factors, postoperative complications outcomes and long term follow up results were analyzed.


Description:

Eight four (84) patients were recruited. The average age of our patients was 49 years (with limits of 20 to 76), the male gender dominates our series (83.33%) with a sex ratio of 5M / 1W, the most frequently found risk factor was diabetes mellitus (37%). The most common etiology was anal abscesses (32%). The average time to consultation was 8 days (limits ranges from 3 to 30 days). All patients were admitted at a necrosis stage (100%). Anemia was identified in 85% of cases. The low platelets were noticed in 44.03% of cases. Hypoalbuminemia was found in 93% of cases. All patients (100%) benefited resuscitation initially and antibiotic therapy on their admission. They received emergency surgical debridement with a cleansing stoma. The average length of hospital stay was 13 days and complications occurred in 33% of cases. The mortality rate was 7.14%. then we conclude that Fournier's gangrene is a medico-surgical emergency with a high morbidity and mortality rate. Early diagnosis as well as antibiotic therapy and the quality of debridement save the patients.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date July 2, 2021
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 100 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Fournier Gangrene Exclusion Criteria: - Other perineal diseases which are differential diagnosis of Fournier gangrene

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Necrotesectomy associated with cleanleness stoma
Excision of all necrotised tissues after stool diversion and wound dressing using

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sylvestre KABURA

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who died for fournier gangrene The mortality rate of patients with Fournier Gangrene after six months Six months
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