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

Not Applicable

Completed

• Conditions: Endoscopic Sinus Surgery
• Interventions: Procedure: classic lateral lamellectomy; Procedure: submucosal conchoplasty

• Registration Number: NCT05930132
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-30
• Study First Submitted: 2023-06-14
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
classic lateral lamellectomy	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.
submucosal conchoplasty	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the time of the technique	during the operation	in minutes
the amount of bleeding	during the operation	in cubic centimeters

Trial Locations

Locations (1)

Kafrelsheikh university; 🇪🇬 Sakha, Kafrelsheikh, Egypt