- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983056
Management of Fournier Gangrene at Ibn Rochd University Hospital Center
July 19, 2021 updated by: Sylvestre KABURA
Fournier's Gangrene: Seven Years of Experience in the Emergencies Service of Visceral Surgery at Ibn Rochd UHC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
84
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
11 years to 96 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
. Patients with Fournier Gangrene
Description
Inclusion Criteria:
- Clinical diagnosis of Fournier Gangrene
Exclusion Criteria:
- Other perineal diseases which are differential diagnosis of Fournier gangrene
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: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients who died for fournier gangrene
Time Frame: Six months
|
The mortality rate of patients with Fournier Gangrene after six months
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2010
Primary Completion (Actual)
March 31, 2017
Study Completion (Actual)
July 2, 2021
Study Registration Dates
First Submitted
July 7, 2021
First Submitted That Met QC Criteria
July 19, 2021
First Posted (Actual)
July 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 30, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FZBKSMP35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
Clinical Trials on Fournier Gangrene
-
Hospital Universitario Dr. Jose E. GonzalezCompletedFournier Gangrene | Fournier's Gangrene of Penis | Fournier's Gangrene of ScrotumMexico
-
Atox Bio LtdBiomedical Advanced Research and Development AuthorityCompletedNecrotizing Fasciitis | Necrotizing Soft Tissue Infections | Fournier's GangreneUnited States, France
-
University of CagliariUniversity of Milano Bicocca; University of Milan; University of Cagliari, Cagliari... and other collaboratorsRecruitingSoft Tissue Infections | Fournier Gangrene | Necrotizing Fascitis | Fournier's GangreneItaly
-
University of Maryland, BaltimoreCubist Pharmaceuticals LLCCompletedFasciitis, Necrotizing | Fournier's Gangrene | Severe Necrotizing Skin and Soft Tissue InfectionsUnited States
-
Henri Mondor University HospitalEuropean Society of Intensive Care MedicineRecruitingFournier Gangrene | Necrotizing Soft Tissue Infection | Necrotizing FasciitisFrance
-
Istanbul Training and Research HospitalCompletedFournier Gangrene | Perianal AbscessTurkey
-
Ole HyldegaardSeventh Framework ProgrammeCompletedPrognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study (ProTreat)Fournier Gangrene | Necrotizing Soft Tissue Infection | Gas Gangrene | Necrotizing FascitisDenmark
-
Ole HyldegaardCompletedFournier Gangrene | Necrotizing Soft Tissue Infection | Necrotizing Fasciitis | Gas GangreneDenmark
-
Anders PernerCSL BehringCompletedFournier Gangrene | Necrotizing Soft Tissue Infection | Necrotizing Fasciitis | Gas GangreneDenmark
-
University of CataniaCompleted
Clinical Trials on Necrotesectomy associated with cleanleness stoma
-
ANO Scientific and Practical Club for the Development...RecruitingLocal Advanced Rectal Cancer | Rectal Cancer Surgery | Low Rectal Cancer | Middle Rectal Cancer | TMERussia
-
Ankara UniversityCompleted
-
Istanbul University - Cerrahpasa (IUC)Active, not recruiting
-
Assiut UniversityNot yet recruiting
-
The Hospital of VestfoldVestre Viken Hospital Trust; Ullevaal University Hospital; Oslo University Hospital and other collaboratorsRecruitingQuality of Life | Rectal Cancer | Ileostomy; Complications | Complication,PostoperativeNorway
-
University Hospital, RouenRecruiting
-
Universidade Federal de PernambucoUnknownDiabetes Mellitus, Type 2Brazil
-
University of Sao PauloCompletedPeriodontal Diseases | Bone DiseasesBrazil
-
Aristotle University Of ThessalonikiLABNET IAE - Private Reference Diagnostic LaboratoryUnknownCoronary Artery Disease | Coronary Arteriosclerosis | Cardiovascular Risk FactorGreece
-
Federal University of ParaíbaUnknown