Computer Assisted Navigation on Endoscopic Sinus Surgery for Treatment of Sinonasal Polyposis

Impact of Computer Assisted Navigation on Endoscopic Sinus Surgery for Treatment of Sinonasal Polyposis

This study aimed to compare Endoscopic Sinus Surgery with and without image guidance, analyzing a number of parameters that can impact efficacy in cases of nasal polyposis.

Study Overview

• Status: Completed
• Conditions: Endoscopic Sinus Surgery; Navigation; Computer Assisted; Sinonasal Polyposis
• Intervention / Treatment: Procedure: Endoscopic sinus surgery with Computer Assisted Navigation; Procedure: Endoscopic sinus surgery

Detailed Description

Endoscopic sinus surgery (ESS) is a treatment of choice for rhinosinusitis (CRS), sinonasal polyposis and in cases of skull base diseases. Despite the availability of excellent nasal telescopes and high-resolution preoperative computed tomography (CT), incidence of complications in endoscopic sinus surgery is of 0-1.5% for the major and 1.1-20.8% for the minor.

Electromagnetic and optical localization systems both enable real-time detection of instrument position in a 3D imaging repository. At present, such repositories are exclusively based on CT acquisitions reformatted to obtain a series of slices in three dimensions. A software interface matches the imaging repository to a peroperative spatial repository in which the instrument can be located.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This Prospective comparative study was carried out on 40 patients aged from above 15 and below 70 years old, both sexes, with nasal polyposis undergoing ESS whether primary or revision cases. The study was done after approval from the Ethical Committee Al Azhar University, Cairo, Egypt.

Description

Inclusion Criteria:

• Age from 15 to 70 years.
• Both sex.
• Patients with nasal polyposis undergoing endoscopic sinus surgery (ESS) whether primary or revision cases.

Exclusion Criteria:

• Patients with nasal polyposis not undergoing ESS.
• Patients with any severe cardiac diseases, pregnant females, transplant patients and patients with psychiatric illness.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Patients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation.	Procedure: Endoscopic sinus surgery with Computer Assisted Navigation; Patients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation.
Group II; Patients with nasal polyposis undergoing endoscopic sinus surgery only.	Procedure: Endoscopic sinus surgery; Patients with nasal polyposis undergoing endoscopic sinus surgery only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Recurrence rate was recorded.	3 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major complications	Incidence of major complications like cerebrospinal fluid (CSF) leakage, Carotid artery injury, Brain injury, Blindness, Orbital hematoma and persistent diplopia were recorded.	3 months after the procedure
Incidence of minor complications	Incidence of minor complications like Orbital fat extrusion, Bleeding, Dural exposure, Nasolacrimal duct injury, Synechiae and edema were recorded	3 months after the procedure

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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