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

NCT05930132 | Completed

• 1 other identifier: MKSU50-9-22
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the time of the technique

  during the operation

• the amount of bleeding

  during the operation

Study Arms (2)

classic lateral lamellectomy

OTHER

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

submucosal conchoplasty

OTHER

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

Interventions

submucosal conchoplasty PROCEDURE

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

submucosal conchoplasty

classic lateral lamellectomy PROCEDURE

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.

classic lateral lamellectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh university

Sakhā, Kafrelsheikh, 33511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of otolaryngology

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 5, 2023
• Study Start: October 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 30, 2020
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)