NCT05979662

Brief Summary

The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and need for corticosteroid to control polyp postoperatively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

July 29, 2023

Last Update Submit

July 29, 2023

Conditions

Endoscopic Frontal Sinus SurgeryChronic Rhinosinusitis With Nasal PolypsDraf IIIDraf I or IIa

Outcome Measures

Primary Outcomes (1)

  • Recurrence of polyp using endoscopic polyp score

    Polyps were evaluated on each side through nasal endoscopy at each visit and graded based on polyp size, resulting in scores of 0 to 4 9. Zero is no polyp, 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = polyps reaching below the lower border of the middle turbinate, 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = large polyps causing complete obstruction of the inferior nasal cavity. The sum of the left and right nostril scores is the Nasal Polyp Score

    One year postoperatively

Secondary Outcomes (2)

  • Lund MacKay score

    One year postoperatively

  • Sinonasal Outcome Test- 22

    One year postoperatively

Study Arms (2)

Group one

EXPERIMENTAL

Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).

Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).

Group two

ACTIVE COMPARATOR

Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).

Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)

Interventions

Endoscopic frontal sinus surgery grade 6(Draf III).PROCEDURE

Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).

Group one
Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)PROCEDURE

Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).

Group two

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months .

You may not qualify if:

  • Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)
  • Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography.
  • Any contraindication for general anesthesia.
  • Patients below age of 18 years.
  • Incomplete follow up
  • previous sinus surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tanta University Hospitals

Tanta, El-Gharbia, 31511, Egypt

RECRUITING

Tanta University

Tanta, El-Gharbia, 31511, Egypt

RECRUITING

Central Study Contacts

Ibrahim T Elshamy, MSc

CONTACT

+20 102 237 3920hematalal93@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Otorhinolaryngology

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 7, 2023

Study Start

January 1, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

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 autho

Locations

EG(2)