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Clinical Trials/NCT05930132
NCT05930132
Completed
Not Applicable

The Role of Using the Submucosal Conchoplasty Technique for the Management of Concha Bullosa in Decreasing the Postoperative Middle Meatus Synechia Formation After Endoscopic Sinus Surgery: A Randomized Controlled Trial

Kafrelsheikh University1 site in 1 country56 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopic Sinus Surgery
Sponsor
Kafrelsheikh University
Enrollment
56
Locations
1
Primary Endpoint
the clinical symptoms before and after the surgery through the Sino-nasal outcome test 22. (SNOT 22)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study aimed to compare the applicability of the classic lateral lamellectomy versus the submucosal conchoplasty techniques in managing the concha bullosa during and after ESS.

Detailed Description

The study included fifty-six patients with bilateral concha bullosa who were undergoing primary ESS for refractory chronic sinusitis. They were divided into two equal groups randomly. One group had the submucosal conchoplasty technique, and the other group had the lateral lamellectomy technique. The study compared the intraoperative findings including the time required for each technique and the amount of intraoperative bleeding. Furthermore, it compared the postoperative endoscopic outcome of the middle meatus and middle turbinate stability using the LKES and the POSE score. Also, the postoperative olfaction outcome was assessed.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
April 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Waheed Elgendy

lecturer of otolaryngology

Kafrelsheikh University

Eligibility Criteria

Inclusion Criteria

  • patients above 18 years
  • patients diagnosed with chronic sinusitis based on the 2012 European Position Paper on Rhino-sinusitis and Nasal Polyps's criteria (EPOS 2012)
  • patients presented by bilateral concha bullosa

Exclusion Criteria

  • patients below 18 years
  • patients with nasal polyps
  • patients with primary ciliary dyskinesia
  • patients with nasal masses
  • revision cases

Outcomes

Primary Outcomes

the clinical symptoms before and after the surgery through the Sino-nasal outcome test 22. (SNOT 22)

Time Frame: Patients were followed up at the end of six month after surgery ( change from baseline )

The study assessed the clinical symptoms before and after the surgery through the Sino-nasal outcome test 22. (SNOT 22)

Secondary Outcomes

  • the time of the technique(during the operation)
  • the amount of bleeding(during the operation)

Study Sites (1)

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