| CTRI Number |
CTRI/2026/01/100202 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of septoplasty with or without turbinoplasty on the symptom profile in patients with deviated nasal septum and inferior turbinate hypertrophy |
|
Scientific Title of Study
|
A comparative study on effect of septoplasty with or without turbinoplasty on the symptom profile in patients with DNS and inferior turbinate hypertrophy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| fahmed853 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Faisal Ahmed |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital |
| Address |
Institute of Otorhinolaryngology and Head Neck Surgery,IPGMER and SSKM Hospital,244 AJC Bose Road,Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9064245643 |
| Fax |
|
| Email |
fahmed853@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arunabha Sengupta |
| Designation |
Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital |
| Address |
Institute of Otorhinolaryngology and Head Neck Surgery,IPGMER and SSKM Hospital,244 AJC Bose Road,Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831089737 |
| Fax |
|
| Email |
arunabhasengupta2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arunabha Sengupta |
| Designation |
Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital |
| Address |
Institute of Otorhinolaryngology and Head Neck Surgery,IPGMER and SSKM Hospital,244 AJC Bose Road,Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831089737 |
| Fax |
|
| Email |
arunabhasengupta2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital,244 AJC Bose Road,Kolkata 700020,West Bengal,India |
|
|
Primary Sponsor
|
| Name |
Dr Arunabha Sengupta |
| Address |
Institute of Otorhinolaryngology and Head Neck Surgery,IPGMER and SSKM Hospital,244 AJC Bose Road,Kolkata |
| Type of Sponsor |
Other [Self [Guide and Unit Head]] |
|
|
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 Faisal Ahmed |
Institute of Otorhinolaryngology and Head Neck Surgery IPGMER and SSKM Hospital |
ENT OPD Unit 1 Room No 6 (on Wednesday and Saturday)Institute of Otorhinolaryngology and Head Neck Surgery,IPGMER and SSKM Hospital,244 AJC Bose Road,Kolkata
Kolkata
WEST BENGAL |
9064245643
fahmed853@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, (2) ICD-10 Condition: J343||Hypertrophy of nasal turbinates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Septoplasty with turbinoplasty |
In patients with deviated nasal septum and inferior turbinate hypertrophy both septoplasty and turbinoplasty is done |
| Comparator Agent |
Septoplasty without turbinoplasty |
In patients with deviated nasal septum and inferior turbinate hypertrophy only septoplasty is done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Having persistent moderate to severe nasal obstruction due to DNS with contralateral hypertrophied inferior turbinate(grades 2 and 3) wil be included. |
|
| ExclusionCriteria |
| Details |
1.Patients with drug allergies and known end organ damage i.e. cerebrovascular diseases, cardiovascular system disorder, Hypertension, asthma or chronic obstructive lung disease, diabetes mellitus, coagulation defect, hepatic or renal failure, malignancy and other debilitating diseases.
2.Age less than 18 years and more than 60 years
3.Patients having craniofacial malformation.
4.Patients having any cause of bilateral inferior turbinate hypertrophy like sinonasal polyposis, allergic rhinitis, sinusitis, chronic hypertrophic rhinitis, septal perforation.
5.Patients who had previous nose surgery were excluded from the study.
6.Patient not willing to participate.
7.Patient unfit for surgery or anaesthesia. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of symptom improvement |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
23/01/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background of present study:
Deviation of nasal septum towards one side is often associated with over growth of
inferior turbinate, which occupies expansive space of contralateral nasal cavity. The enlargement of inferior turbinate can be due to mucosal elements or bony expansion. Many surgeons are of the belief if septoplasty is done, compensatory hypertrophy
regresses on its own. There are others who argue that these changes are not
spontaneously reversible and should be corrected in conjunction with nasal septal
surgery. Otherwise, surgery may relieve the obstruction on one side of nose but leave other side of obstructed because of relocation of septum towards hypertrophied turbinate.
Rationale of study: IORL-HNS at SSKM Hospital caters to a large number of
patients with nasal blockage among the patients presenting in the OPD of IORLHNS. Septoplasty in these patients is regarded as the beneficial treatment option when medical management fails. But there are very few studies regarding Septoplasty with or without turbinoplasty. Hence, there is a need to examine the various aspects of these two procedures and their outcomes.
This study aims -
1. By doing this study we want to find out whether reduction of hypertrophied inferior
turbinate should be considered along with septoplasty or septoplasty alone can treat
nasal obstruction in patients with DNS.
2. Comparing the subjective improvement in obstruction of nose following Septoplasty
along with Inferior turbinoplasty Versus Septoplasty alone using NOSE (Nasal
Obstruction Symptom Evaluation) Scale in the patients of Deviated Nasal Septum. |