Endoscopic Repair of Frontal Sinus CSF Leak | NCT05024643

Studies
Endoscopic Repair of Frontal Sinus CSF Leak

NCT05024643

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Aug 27, 2021Actual

Enrollment

27Actual

Phase

Not provided

Conditions

CSF Leakage

Interventions

Endonasal endoscopy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2015Actual

Primary Completion Date

Dec 20, 2020Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Aug 22, 2021

First Submission Date that Met QC Criteria

Aug 22, 2021

First Posted Date

Aug 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2021

Last Update Posted Date

Aug 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful treatment	Intracranial tension from 7-15 mmHg, No leakage, No complications	1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002559	Cerebrospinal Fluid Rhinorrhea

Ancestor Terms

ID	Term
D065634	Cerebrospinal Fluid Leak
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

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Browse Branches

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