| CTRI Number |
CTRI/2026/01/102176 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| 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
|
A study comparing two surgical methods to improve nasal breathing in patients with nasal blockage |
|
Scientific Title of Study
|
Surgical outcome of Microdebrider-Assisted Turbinoplasty Versus Submucosal Diathermy Turbinoplasty -A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GUDURU LAKSHMI RAHUL |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai veedu Medical College |
| Address |
Department Of ENT , Aarupadai veedu Medical College,Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8341668369 |
| Fax |
|
| Email |
lakshmirahul.g1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ATUL MUKUL BAGE |
| Designation |
Professor and Head of the Department |
| Affiliation |
Aarupadai veedu Medical College |
| Address |
Department of ENT , Aarupadai veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9443292716 |
| Fax |
|
| Email |
atulbage25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GUDURU LAKSHMI RAHUL |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai veedu Medical College |
| Address |
Department of ENT, Aarupadai veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8341668369 |
| Fax |
|
| Email |
lakshmirahul.g1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF FUNDED
Department Of ENT , Aarupadai veedu Medical College,Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry, India 607403
|
|
|
Primary Sponsor
|
| Name |
DR GUDURU LAKSHMI RAHUL |
| Address |
DEPARTMENT OF ENT , AARUPADAI VEEDU MEDICAL COLLEGE, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607403 |
| Type of Sponsor |
Other [Self] |
|
|
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 GUDURU LAKSHMI RAHUL |
AARUPADAI VEEDU MEDICAL COLLEGE |
Room no: 9,C block,Department of ENT,Aarupadai veedu medical college,Puducherry
Pondicherry
PONDICHERRY |
8341668369
lakshmirahul.g1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, Aarupadai Veedu Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J343||Hypertrophy of nasal turbinates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microdebrider assisted turbinoplasty |
Microdebrider-assisted inferior turbinoplasty will be performed under local or general anesthesia. After nasal decongestion and submucosal infiltration with lignocaine and adrenaline, an anterior mucosal incision is made on the inferior turbinate. A Microdebrider is used for 10mints to remove hypertrophied submucosal tissue ± bone under endoscopic guidance , preserving the mucosa. Hemostasis is achieved with adrenaline pledgets or minimal cautery. Nasal packing is done only if required, followed by standard postoperative care. |
| Comparator Agent |
Sub mucosal diathermy turbinoplasty |
Submucosal diathermy of the inferior turbinate will be performed under local or general anesthesia. After nasal decongestion and lignocaine–adrenaline infiltration, a diathermy needle is inserted submucosally and controlled cauterization is applied along the turbinate for 5 minutes to reduce hypertrophied tissue while preserving mucosa. Nasal packing is done only if required, followed by routine postoperative care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 to 60 years.
2. Both male and female patients.
3. Patients with isolated inferior turbinate hypertrophy.
4. Patients with nasal obstruction not responding to medical management. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study.
2. Presence of nasal polyposis.
3. Patients deemed unfit for surgery due to medical comorbidities.
4. Patients with previous history of inferior turbinoplasty or turbinate surgery. |
|
|
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 Microdebrider-assisted Turbinoplasty versus Submucosal Diathermy Turbinoplasty in providing relief of nasal symptoms |
To follow up patients at 1week,1month and 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the severity of postoperative complications between Microdebrider-assisted Turbinoplasty versus Submucosal Diathermy Turbinoplasty |
To follow up patients at 1week,1month and 3months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
05/02/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Inferior turbinate hypertrophy is a common cause of chronic nasal obstruction when medical management fails. Various surgical techniques are available for turbinate reduction, of which microdebrider-assisted turbinoplasty and submucosal diathermy turbinoplasty are commonly performed. This randomized controlled trial aims to compare the surgical outcomes of these two techniques in terms of improvement in nasal symptoms and postoperative complications. Eligible patients will be randomized into two groups and followed up at 1 week, 1 month, and 3 months postoperatively using validated symptom scores. The results of this study may help guide the selection of an effective and safe surgical technique for inferior turbinate hypertrophy.
|