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Completed

NCT Number: NCT05930132

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

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.

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Key information

Conditions

Endoscopic Sinus Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh university

Sakhā, Kafrelsheikh, 33511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  1. the time of the technique

    Time frame: during the operation

    in minutes

  2. the amount of bleeding

    Time frame: during the operation

    in cubic centimeters

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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