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

Endoscopic Sinus Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930132
• Other study ID #: MKSU50-9-22
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 30, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Sinus Surgery

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh university	Sakha	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the clinical symptoms before and after the surgery through the Sino-nasal outcome test 22. (SNOT 22)	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	the time of the technique	in minutes	during the operation
Secondary	the amount of bleeding	in cubic centimeters	during the operation