Endoscopic Repair of Frontal Sinus CSF Leak

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.

Study Overview

• Status: Completed
• Conditions: CSF Leakage
• Intervention / Treatment: Procedure: Endonasal endoscopy

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 Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with frontal sinus leaks attended Al-Azhar University Hospital, New Damietta, Egypt

Description

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

Study Plan

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
Successful treatment	Intracranial tension from 7-15 mmHg, No leakage, No complications	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Elevated intracranial tension, more than 15 mmHg, Fever, more than 37.5 degree, Meningitis	1 week

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cerebrospinal Fluid Leak
• Other Study ID Numbers: 21-01-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No