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Clinical Trials/CTRI/2024/12/078159
CTRI/2024/12/078159RecruitingPhase 3 4

To Assess The Effectiveness Of Lateral Partial Turbinectomy Versus Submucosal Conchoplasty For Concha Bullosa- A Randomized Controlled Trial

Dilshada P1 site in 1 country60 target enrollmentStarted: December 25, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To assess the effectiveness of Lateral Partial Turbinectomy (LPT) and Submucosal Conchoplasty (SMC) in providing relief of nasal symptoms in patients diagnosed with concha bullosa.

Study Overview

Brief Summary

The middle turbinate is originated from the medial part of the ethmoid bone. The middle turbinate is divided into three parts depending on its attachment and its orientation in the three dimension space. The anterior one-third of the middle turbinate is in the sagittal plane and attached to the cribriform plate at the junction of the medial and lateral lamella. It also takes attachment to the frontonasal process of the maxilla. The middle one-third of the middle turbinate in the coronal plane is attached to the lamina papyracea. The posterior one-third of the middle turbinate is attached in the horizontal pane to the lamina papyracea and perpendicular plate of the palatine bone.[1]

Pneumatization of the middle turbinate is known as concha bullosa. It can affect any of the turbinates, but the middle turbinate is the most commonly involved one. Sufficiently large concha bullosa can cause significant problems like headache, nasal obstruction and blockage of sinus drainage leading to sinonasal disease. Commonly the concha bullosa contains only a single air cell. Multiple air cells in a concha bullosa are relatively rare. Concha bullosa can exist unilaterally or bilaterally and it can be further classified into three groups according to the location and size of pneumatization: They are the lamellar-type, bulbous-type and extensive-type of concha bullosa. [3]

There are many different approaches for the surgical treatment of concha bullosa, such as lateral or medial partial resection, total resection, turbinoplasty, crushing and crushing with intrinsic stripping.[4] Each of these procedures has its own advantages and disadvantages. Two of the commonly done endoscopic procedures for concha bullosa are lateral partial turbinectomy (LPT) and Submucosal conchoplasty.[2]

For lateral laminectomy, the anterior and lateral parts of the pneumatized middle turbinate, including both the covering mucosa and underlying bone, were removed by leaving back only the inferio-medial half of the middle turbinate. [3]

For conchoplasty technique, following a midline incision of an areated middle turbinate with a sickle knife , which was done at the inferior and anterior end of the turbinate in the saggital plane direction. This incision was then prolonged posteriorly. Starting from the incision line, and by careful dissection, a plane between the bony walls of the concha bullosa and its mucoperiosteal covering was created with subsequent formation of superiorly and posteriorly based mucosal flaps medially and laterally, which then was raised untill the bony lateral lamella could be removed.  The mucosal flaps were reposited with application of gel film, so reducing the size of the turbinate, without disturbance of its covering mucosa and retaining its original shape.[3]

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients diagnosed with concha bullosa confirmed through clinical examination and imaging studies.
  • Adults aged 18 to 65 years.

Exclusion Criteria

  • Patients with significant comorbidities.

Outcomes

Primary Outcomes

To assess the effectiveness of Lateral Partial Turbinectomy (LPT) and Submucosal Conchoplasty (SMC) in providing relief of nasal symptoms in patients diagnosed with concha bullosa.

Time Frame: 1 week, 1 month, 3 months

Secondary Outcomes

  • To compare the severity of postoperative complications between LPT and SMC in patients with concha bullosa.(1 week, 1 month, 3 months)

Investigators

Sponsor
Dilshada P
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dilshada P

Aarupadai Veedu Medical College & Hospital

Study Sites (1)

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