Fournier GangreneNCT04983056
Management of Fournier Gangrene at Ibn Rochd University Hospital Center
An observational study of Fournier Gangrene, run by Sylvestre KABURA.
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. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Fournier Gangrene
- What is being tested?
- Necrotesectomy associated with cleanleness stoma
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 2 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: . Patients with Fournier Gangrene
Who may be able to join
- Clinical diagnosis of Fournier Gangrene
Who cannot join
- Other perineal diseases which are differential diagnosis of Fournier gangrene
About this study
Official title: 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.
Read the 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.
- Conditions
- Fournier Gangrene
- Being tested
- Necrotesectomy associated with cleanleness stoma
- Keywords
- Fournier's Gangrene, stoma, necrosectomy
- Medical subject headings
- Fournier Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necrotesectomy associated with cleanleness stomaProcedure or surgery
Excision of all necrotised tissues after stool diversion and wound dressing using
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who died for fournier gangrene
The mortality rate of patients with Fournier Gangrene after six months
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jan 2010
- Primary completion31 Mar 2017
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fournier GangreneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylvestre KABURA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvestre KABURA, Centre Hospitalier Universitaire Ibn Rochd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983056
- Sponsor's protocol ID
- FZBKSMP35
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fournier's Gangrene: Seven Years of Experience in the Emergencies Service of Visceral Surgery at Ibn Rochd UHC
- ClinicalTrials.gov ID
- NCT04983056
- Acronym / sponsor ID
- FZBKSMP35
- Conditions
- Fournier Gangrene
- Keywords
- Fournier's Gangrene, stoma, necrosectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sylvestre KABURAUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- . Patients with Fournier Gangrene
Key inclusion criteria (1 listed)
- Clinical diagnosis of Fournier Gangrene
Key exclusion criteria (1 listed)
- Other perineal diseases which are differential diagnosis of Fournier gangrene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Necrotesectomy associated with cleanleness stomaExcision of all necrotised tissues after stool diversion and wound dressing using | Procedure or surgery | – |
Primary outcome
Number of patients who died for fournier gangrene
Time frame: Six months
The mortality rate of patients with Fournier Gangrene after six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Fournier Gangrene
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RecruitingObservational study
FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).
Necrotizing Fascitis, Fournier Gangrene
Enrolling by invitationObservational study
Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infection, Fournier Gangrene
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fournier Gangrene, run by Sylvestre KABURA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who died for fournier gangrene (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.