Skip to main content
OpenTrials
Completed

NCT Number: NCT05024643

Endoscopic Repair of Frontal Sinus CSF 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Csf Leakage Cerebrospinal Fluid Leak Cerebrospinal Fluid Rhinorrhea Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rhinorrhea Signs and Symptoms Signs and Symptoms, Respiratory Trauma, Nervous System Wounds and Injuries

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endonasal endoscopy

Procedure

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.

Primary outcomes

  1. Successful treatment

    Time frame: 1 year

    Intracranial tension from 7-15 mmHg, No leakage, No complications

Secondary outcomes

  1. Complications

    Time frame: 1 week

    Elevated intracranial tension, more than 15 mmHg, Fever, more than 37.5 degree, Meningitis

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Outcome of the Endoscopic Repair of Frontal Sinus Cerebrospinal Fluid Leak

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.