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OpenTrials
Completed

NCT Number: NCT07575022

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.

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Key information

Conditions

Computer Assisted Endoscopic Sinus Surgery Navigation Sinonasal Polyposis

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Azhar University

Cairo, 11651, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Endoscopic sinus surgery with Computer Assisted Navigation

Procedure

Patients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation.

Endoscopic sinus surgery

Procedure

Patients with nasal polyposis undergoing endoscopic sinus surgery only.

Primary outcomes

  1. Recurrence rate

    Time frame: 3 months after the procedure

    Recurrence rate was recorded.

Secondary outcomes

  1. Incidence of major complications

    Time frame: 3 months after the procedure

    Incidence of major complications like cerebrospinal fluid (CSF) leakage, Carotid artery injury, Brain injury, Blindness, Orbital hematoma and persistent diplopia were recorded.

  2. Incidence of minor complications

    Time frame: 3 months after the procedure

    Incidence of minor complications like Orbital fat extrusion, Bleeding, Dural exposure, Nasolacrimal duct injury, Synechiae and edema were recorded

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2026
Registry last updated
May 8, 2026

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.

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