| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ANYONE WHO NEEDS THE DATA KINDLY CONTACT ME ON dilshadapulikal@gmail.com
- 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.
- 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] |