| CTRI Number |
CTRI/2023/09/057857 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
16/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the results of two surgical procedure done for deviated nasal septum |
|
Scientific Title of Study
|
Subjective outcome following Septoplasty with Turbinoplasty in comparison to Septoplasty without Turbinoplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Iadarity A Nongkynrih |
| Designation |
Post Graduate Trainee |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Otorhinolaryngology, Silchar Medical College and Hospital, Silchar.
Cachar
ASSAM
788014
India |
| Phone |
8974947712 |
| Fax |
|
| Email |
iadaritynongkynrih4451@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smrity R B Dutta |
| Designation |
Professor and head of the department |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Otorhinolaryngology, Silchar Medical College and Hospital, Silchar.
Cachar
ASSAM
788014
India |
| Phone |
9435348294 |
| Fax |
|
| Email |
smritylana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smrity RB Dutta |
| Designation |
Professor and Head of Department |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Otorhinolaryngology, Silchar Medical College and Hospital, Silchar.
Cachar
ASSAM
788014
India |
| Phone |
9435348294 |
| Fax |
|
| Email |
smritylana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital,Silchar, Assam |
|
|
Primary Sponsor
|
| Name |
Silchar Medical College and Hospital |
| Address |
Silchar Medical College and Hospital, Ghungoor,Silchar, Cachar, Assam |
| Type of Sponsor |
Government 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 Iadarity A Nongkynrih |
Silchar Medical College and Hospital, Silchar, Assam |
Department of Otorhinolaryngology, Silchar Medical College and hospital
Cachar
ASSAM |
8974947712
iadaritynongkynrih4451@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Silchar Medical College and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Septoplasty and Septoplasty with Turbinoplasty |
In this study, patients with symptomatic deviated nasal septum with inferior turbinate hypertrophy were selected and divided into two groups. One group underwent septoplasty alone whereas the other group underwent septoplasty with turbinoplasty of the inferior turbinate. |
| Comparator Agent |
Septoplasty with and without turbinoplasty |
This study aims to compare the subjective outcome of nasal symptoms in cases of symptomatic deviated nasal septum with contralateral inferior turbinate hypertrophy following septoplasty with turbinoplasty in comparison to septoplasty without turbinoplasty. A through examination, nasal endoscopy is done pre and post-operatively and the patients are asked to complete a questionnaire using the NOSE and SNOT-22 to assess their symptoms. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptomatic deviated nasal septum with inferior turbinate hypertrophy.
Patients refractory to medical management. |
|
| ExclusionCriteria |
| Details |
Patients who have undergone previous nasal surgeries.
Patient who have acute on chronic rhinosinusitis,perforated nasal septum, granulomatous condition of nose and sinuses, craniofacial malformation
Pregnant woman.
Patients with uncontrolled systemic disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Releive of nasal symptoms. |
The patient is assessed at 1 month, 3 months & 6 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life |
It is assessed at 1 month, 3 months & 6 months follow-up |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
26/09/2023 |
| 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="0"
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
|
A deviated nasal symptom is among the frequent causes of nasal bolckage, headache, chronic sinusitis and cosmetic deformity. The deviated nasal septum is mostly accompanied by an inferior turbinate hypertrophy, usually contralateral turbinate hypertrophy. This inferior turbinate hypertrophy can be osseous or mucosal.
The correction of the deviated nasal septum can be achieved by a surgical procedure called Septoplasty. Septoplasty is a conservative procedure for septal deviation correction, where only the deviated part of the nasal septum is removed and corrected. Tubinoplasty is a surgical procedure that reducesn in the size of the turbinates which can be done by cauterisation, coblation or partial resection.
In cases of nasal obstuction due to deviated nasal septum and inferior turbinate hypertrophy, surgical correction can be done, that is, septoplasty alone or septoplasty combined with turbinoplasty to releive the nasal symptoms. |