FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078159 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessing The Effectiveness Of Partial Turbinectomy Versus Submucosal Conchoplasty For Concha Bullosa 
Scientific Title of Study   To Assess The Effectiveness Of Lateral Partial Turbinectomy Versus Submucosal Conchoplasty For Concha Bullosa- A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dilshada P 
Designation  PG student  
Affiliation  Aarupadai Veedu Medical College & Hospital 
Address  OPD NO: 9 Department of Otorhinolaryngology Aarupadai Veedu Medical College & Hospital Commune Panchayat Pondy Cuddalore Main road Kirumampakkam Bahour Kirumampakkam Puducherry 607402

Pondicherry
PONDICHERRY
607402
India 
Phone  8547557163  
Fax    
Email  dilshadapulikal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ATUL M BAGE 
Designation  HEAD OF DEPARTMENT-ENT 
Affiliation  Aarupadai Veedu Medical College & Hospital 
Address  OPD NO: 9 Department of Otorhinolaryngology Aarupadai Veedu Medical College & Hospital Commune Panchayat Pondy Cuddalore Main road Kirumampakkam Bahour Kirumampakkam Puducherry 607402

Pondicherry
PONDICHERRY
607402
India 
Phone  9443292716  
Fax    
Email  otorhinolaryngology@avmc.edu.in  
 
Details of Contact Person
Public Query
 
Name  ATUL M BAGE 
Designation  HEAD OF DEPARTMENT-ENT 
Affiliation  Aarupadai Veedu Medical College & Hospital 
Address  OPD NO: 9 Department of Otorhinolaryngology Aarupadai Veedu Medical College & Hospital Commune Panchayat Pondy Cuddalore Main road Kirumampakkam Bahour Kirumampakkam Puducherry 607402

Pondicherry
PONDICHERRY
607402
India 
Phone  9443292716  
Fax    
Email  otorhinolaryngology@avmc.edu.in  
 
Source of Monetary or Material Support  
Aarupadai Veedu Medical College & Hospital Kirumampakkam Pondicherry Pincode 607402 India  
 
Primary Sponsor  
Name  Dilshada P 
Address  OPD NO: 9 Department of Otorhinolaryngology Aarupadai Veedu Medical College & Hospital Commune Panchayat Pondy Cuddalore Main road Kirumampakkam Bahour Kirumampakkam Puducherry 607402 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dilshada P  Aarupadai Veedu medical college and hospital   OP NO 9 Department of Otorhinolaryngology Aarupadai Veedu Medical College & Hospital Commune Panchayat Pondy Cuddalore Main road Kirumampakkam Bahour Kirumampakkam Puducherry 607402
Pondicherry
PONDICHERRY 
8547557163

dilshadapulikal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Commitee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J349||Unspecified disorder of nose and nasal sinuses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lateral partial turbinectomy  Lateral partial turbinectomy will be done in one group of patients. 
Comparator Agent  Submucosal Conchoplasty  Submucosal Conchoplasty will be done in the other group of patients  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with concha bullosa confirmed through clinical examination and imaging studies.
2. Adults aged 18 to 65 years.
 
 
ExclusionCriteria 
Details  1. Patients with significant comorbidities  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  1 week, 1 month, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the severity of postoperative complications between LPT and SMC in patients with concha bullosa.  1 week, 1 month, 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  ANYONE WHO NEEDS THE DATA KINDLY CONTACT ME ON dilshadapulikal@gmail.com

  6. For how long will this data be available start date provided 10-06-2026 and end date provided 10-10-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

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]

 
Close