| CTRI Number |
CTRI/2017/08/009397 [Registered on: 17/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare an operation in nose and non-operative treatment with medicines to find out the better method in relieving nose blockage in patients with bent wall in the centre of the nose. |
|
Scientific Title of Study
|
Comparison of the efficacy of septoplasty with non –surgical management in improving nasal obstruction in patients with deviated nasal septum- A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GSDHARANYA |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of ENT
Ward numbers 22 and 24
JIPMER,
Dhanvantri Nagar ,
Pondicherry- 605006
14B , Kalyanasundaram Street ,
Anandha Nagar,
Pondicherry - 605009
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9655021120 |
| Fax |
|
| Email |
natural.dharanyasrinivasan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JYOTIRMAY S HEGDE |
| Designation |
Assistant Professor, Department of ENT, JIPMER |
| Affiliation |
JIPMER |
| Address |
Dhanvantri Nagar ,
Pondicherry- 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843374639 |
| Fax |
|
| Email |
jshegdesirsi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GS DHARANYA |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of ENT
Ward numbers 22 and 24
JIPMER,
Dhanvantri Nagar ,
Pondicherry- 605006
14B , Kalyanasundaram Street ,
Anandha Nagar,
Pondicherry - 605009
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9655021120 |
| Fax |
|
| Email |
natural.dharanyasrinivasan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER)
Dhanvantri Nagar ,
Pondicherry- 605006 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| GSDHARANYA |
JIPMER |
Department of ENT:
Out-patient ward- number 72 and in-patient wards- number 22 and 24.
Pondicherry
PONDICHERRY |
9655021120
natural.dharanyasrinivasan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE (HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
GENERAL CONDITION FAIR, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Non surgical management |
The medical management of DNS includes nasal decongestants, antihistamines and nasal steroid sprays. |
| Intervention |
Septoplasty |
Septoplasty is the surgical correction of deviated nasal septum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age with nasal obstruction due to DNS |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of previous septal surgery
2. Septoplasty done for indications other than deviated nasal septum
3. Patients with a strong preference to surgery will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We expect surgical correction of deviated nasal septum by septoplasty to improve the nasal obstruction better than non-surgical management |
1, 3, 6 months post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We expect surgical correction of deviated nasal septum by septoplasty to improve the nasal obstruction better than non-surgical management both subjectively with peak nasal inspiratory flow and objectively with visual analogue scale , sino nasal outcome test-22, nasal obstruction symptom evaluation scales |
140 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Septoplasty , the surgical correction of deviated nasal septum , is one of the most common ENT surgeries in adults. Currently , the main indication to perform septoplasty is nasal obstruction due to deviated nasal septum. However , the effectiveness of septoplasty in relieving nasal obstruction remains uncertain. The objective of this study is to compare the efficacy of septoplasty with non surgical management in improving nasal obstruction in patients with deviated nasal septum both objectively with NASAL PEAK INSPIRATORY FLOW (NPIF) and subjectively with VISUAL ANALOGUE SCALE (VAS) , SINO NASAL OUTCOME TEST 22 ( SNOT-22) and NASAL OBSTRUCTION SYMPTOM EVALUATION ( NOSE) scales. |