NCT05024643

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

5.6 years

First QC Date

August 22, 2021

Last Update Submit

August 22, 2021

Conditions

CSF Leakage

Outcome Measures

Primary Outcomes (1)

  • Successful treatment

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

    1 year

Secondary Outcomes (1)

  • Complications

    1 week

Interventions

Endonasal endoscopyPROCEDURE

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.

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid LeakNeurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsRhinorrheaSigns and Symptoms, RespiratoryWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory manager

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 27, 2021

Study Start

May 1, 2015

Primary Completion

December 20, 2020

Study Completion

April 1, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08