Endoscopic Repair of Frontal Sinus CSF Leak

CSF Leakage Clinical Trial

Official title:

Outcome of the Endoscopic Repair of Frontal Sinus Cerebrospinal Fluid Leak

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024643
• Other study ID #: 21-01-010
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: April 1, 2021

Study information

• Verified date: August 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 1, 2021
• Est. primary completion date: December 20, 2020
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known malignancy or patients with frontal leak due to extensive tumor resection or intracranial injury

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• CSF Leakage

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful treatment	Intracranial tension from 7-15 mmHg, No leakage, No complications	1 year
Secondary	Complications	Elevated intracranial tension, more than 15 mmHg, Fever, more than 37.5 degree, Meningitis	1 week