The Role of the Submucosal Conchoplasty Technique in Improving the Postoperative Middle Meatus Outcome After ESS

July 3, 2023 updated by: Ahmed Waheed Elgendy, Kafrelsheikh University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kafrelsheikh
      • Sakha, Kafrelsheikh, Egypt, 33511
        • Kafrelsheikh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • smokers
  • patients with nasal polyps
  • patients with primary ciliary dyskinesia
  • patients with nasal masses
  • revision cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: classic lateral lamellectomy

Regarding the lateral lamellectomy technique, the concha was locally infiltrated with adrenaline with a concentration of 1:200,000; the sickle knife was used to open the concha then the scissor was used to remove the lateral lamella with its covering mucosa in one block.

No middle meatus packing was applied. Systemic antibiotics and steroids (0.5 mg / kg prednisolone) were given for two weeks after the surgery. The patients were instructed to use local nasal irrigations (2 ml of budesonide 0.5 mg / ml mixed with 250 ml of normal saline) two times daily for a month postoperatively. Patients were followed up at the end of each month throughout the six months follow-up period.
Procedure: classic lateral lamellectomy

Regarding the lateral lamellectomy technique, the concha was locally infiltrated with adrenaline with a concentration of 1:200,000; the sickle knife was used to open the concha then the scissor was used to remove the lateral lamella with its covering mucosa in one block.

No middle meatus packing was applied. Systemic antibiotics and steroids (0.5 mg / kg prednisolone) were given for two weeks after the surgery. The patients were instructed to use local nasal irrigations (2 ml of budesonide 0.5 mg / ml mixed with 250 ml of normal saline) two times daily for a month postoperatively. Patients were followed up at the end of each month throughout the six months follow-up period.
Other: submucosal conchoplasty
Regarding the submucosal conchoplasty technique, the concha was locally infiltrated with adrenaline with a concentration of 1:200,000. The mucosa was incised by blade 15 starting from the axilla posteriorly up to the attachment with the basal lamella. The mucosa covering the lateral lamella was dissected using the freer dissector. The lateral lamella was removed using a through cut forceps then the mucosa was repositioned. The bony skeleton of the medial lamella was preserved
Procedure: submucosal conchoplasty
Regarding the submucosal conchoplasty technique, the concha was locally infiltrated with adrenaline with a concentration of 1:200,000. The mucosa was incised by blade 15 starting from the axilla posteriorly up to the attachment with the basal lamella. The mucosa covering the lateral lamella was dissected using the freer dissector. The lateral lamella was removed using a through cut forceps then the mucosa was repositioned. The bony skeleton of the medial lamella was preserved

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time of the technique
Time Frame: during the operation
in minutes
during the operation
the amount of bleeding
Time Frame: during the operation
in cubic centimeters
during the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MKSU50-9-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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