CSF LeakageNCT05024643
Endoscopic Repair of Frontal Sinus CSF Leak
An observational study of CSF Leakage, run by Al-Azhar University.
Trial summary
This retrospective study was conducted on patients with frontal sinus leaks came to ENT departments of Al-Azhar University Hospital, New Damietta, Egypt, for a period of five years. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- CSF Leakage
- What is being tested?
- Endonasal endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 Apr 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 10 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with frontal sinus leaks attended Al-Azhar University Hospital, New Damietta, Egypt
Who may be able to join
- patients who underwent endoscopic frontal sinus repair. Traumatic or spontaneous patients with a CSF leak at a minimum of six months not responding to conservative measures were included.
Who cannot join
- Known malignancy or patients with frontal leak due to extensive tumor resection or intracranial injury
About this study
Official title: Outcome of the Endoscopic Repair of Frontal Sinus Cerebrospinal Fluid Leak
This retrospective study was conducted on patients with frontal sinus leaks came to ENT departments of Al-Azhar University Hospital, New Damietta, Egypt, for a period of five years.
Read the detailed description
All patients in this study were evaluated during the follow-up period. Patients' age, sex, occupation, residence, and telephone number were recorded for each participant for demographic purposes. General and local examinations were also performed preoperatively as usual.
Medical history, surgical approach, leakage site, complications, reconstruction technique, and follow-up were recorded.
All cases were treated by endonasal endoscopy
- Complete sphenoethmoidectomy.
- Draf type IIa, IIb, and III according to defect location.
- Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa.
- Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata.
- Conditions
- CSF Leakage
- Being tested
- Endonasal endoscopy
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endonasal endoscopyProcedure or surgery
Complete sphenoethmoidectomy; Draf type IIa, IIb, and III according to defect location.
Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa.
Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata.
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment
Intracranial tension from 7-15 mmHg, No leakage, No complications
Measured: 1 year
Secondary outcomes (1)
Complications
Elevated intracranial tension, more than 15 mmHg, Fever, more than 37.5 degree, Meningitis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 May 2015
- Primary completion20 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF LeakageStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024643
- Sponsor's protocol ID
- 21-01-010
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of the Endoscopic Repair of Frontal Sinus Cerebrospinal Fluid Leak
- ClinicalTrials.gov ID
- NCT05024643
- Acronym / sponsor ID
- 21-01-010
- Conditions
- CSF Leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 27 Aug 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.
This retrospective study was conducted on patients with frontal sinus leaks came to ENT departments of Al-Azhar University Hospital, New Damietta, Egypt, for a period of five years.
Detailed description
All patients in this study were evaluated during the follow-up period. Patients' age, sex, occupation, residence, and telephone number were recorded for each participant for demographic purposes. General and local examinations were also performed preoperatively as usual.
Medical history, surgical approach, leakage site, complications, reconstruction technique, and follow-up were recorded.
All cases were treated by endonasal endoscopy
- Complete sphenoethmoidectomy.
- Draf type IIa, IIb, and III according to defect location.
- Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa.
- Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with frontal sinus leaks attended Al-Azhar University Hospital, New Damietta, Egypt
Key inclusion criteria (1 listed)
- patients who underwent endoscopic frontal sinus repair. Traumatic or spontaneous patients with a CSF leak at a minimum of six months not responding to conservative measures were included.
Key exclusion criteria (1 listed)
- Known malignancy or patients with frontal leak due to extensive tumor resection or intracranial injury
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 |
|---|---|---|
| Endonasal endoscopyComplete sphenoethmoidectomy; Draf type IIa, IIb, and III according to defect location. Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa. Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata. | Procedure or surgery | – |
Primary outcome
Successful treatment
Time frame: 1 year
Intracranial tension from 7-15 mmHg, No leakage, No complications
1 secondary outcome
Complications
Time frame: 1 week
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 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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 CSF Leakage, run by Al-Azhar University.
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 27 Aug 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?
Successful treatment (time frame: 1 year). 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 27 Aug 2021.