NCT07748806

Brief Summary

Introduction The frontal recess is a narrow and anatomically variable region that forms the frontal sinus drainage pathway. Variations in its anatomy, particularly those related to the agger nasi cell and other frontal recess cells, can impair frontal sinus drainage and contribute to the development of frontal sinus disease. High-resolution computed tomography and endoscopic evaluation are essential for identifying these variations and planning endoscopic sinus surgery. A thorough understanding of frontal recess anatomy is crucial for achieving adequate frontal sinus drainage, improving surgical outcomes, and minimizing complications due to the close proximity of the orbit and skull base. The Study aim to evaluate the anatomical variations of the frontal recess using radiological and surgical assessment and determine their significance in the management of frontal sinus disorders during endoscopic sinus surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
Last Updated

August 6, 2026

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

July 29, 2026

Last Update Submit

July 31, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Size distribution of Agar nasi cells

    Distribution of different sizes of agar nasi cells among the participants: small, medium, and large

    Baseline

  • Prevalence of aggar nasi cell

    The frequency of presence of aggar nasi cells on one side, bilateral, or absent

    Baseline

Study Arms (1)

patients presneted with chronic frontal sinusitis refreactory to medical treatment

OTHER

Patients who fulfill the inclusion criteria will undergo endoscopic sinus surgery and a CT scan to detect the anatomical variation of the frontal sinus, frontal recess, and the correlation of this viarations on surgical easiness

Procedure: endosocpic sinus surgery

Interventions

Endoscopic sinus surgery to drain the frontal sinus and detect how easy it will be during surgery and its relation to anatomical variations

patients presneted with chronic frontal sinusitis refreactory to medical treatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age : (20 -60 years old ).
  • Sex: both males and females.
  • Patients were selected from the otorhinolaryngology outpatient clinic of Al-Azhar University Hospital in Assiut in a consecutive manner.
  • All patients were generally well and fit for surgery.

You may not qualify if:

  • Patients with massive inflammatory disease of specific in
  • infections (e.g., rhinoscleroma).
  • Malignancy.
  • Severe nasal trauma.
  • Foreign body.
  • Previous nasal surgery.
  • Atrophic diseases or systemic diseases and patients not fit for surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar university Hopital in Assiut

Asyut, Egypt

Location

MeSH Terms

Conditions

Frontal Sinusitis

Condition Hierarchy (Ancestors)

SinusitisRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENT Specialist

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 6, 2026

Study Start

September 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

August 6, 2026

Record last verified: 2025-09

Locations