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

NCT07575022 | Completed

• 1 other identifier: 1690
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Computer Assisted; Navigation; Endoscopic Sinus Surgery; Sinonasal Polyposis

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  Recurrence rate was recorded.

  3 months after the procedure

Secondary Outcomes (2)

• Incidence of major complications

  3 months after the procedure

• Incidence of minor complications

  3 months after the procedure

Study Arms (2)

Group I

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

Procedure: Endoscopic sinus surgery with Computer Assisted Navigation

Group II

Patients with nasal polyposis undergoing endoscopic sinus surgery only.

Procedure: Endoscopic sinus surgery

Interventions

Endoscopic sinus surgery with Computer Assisted Navigation PROCEDURE

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

Group I

Endoscopic sinus surgery PROCEDURE

Patients with nasal polyposis undergoing endoscopic sinus surgery only.

Group II

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Otorhinolaryngology, Al-Azhar University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)