| CTRI Number |
CTRI/2020/01/022725 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
28/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison between 2 different techniques of performing deviated nasal septum correction surgery |
|
Scientific Title of Study
|
Comparison of the effiacy of endoscopic and conventional techniques of septoturbinoplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishan Sardesai |
| Designation |
Junior Resident, Department of ENT, KMC Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT-Head and Neck Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ishansardesai@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Ranjan Nayak |
| Designation |
Professor and Head of Unit, Department of ENT, KMC Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT-Head and Neck Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drnent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ishan Sardesai |
| Designation |
Junior Resident, Department of ENT, KMC Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT-Head and Neck Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ishansardesai@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Tiger Circle Road, Madhavnagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Ishan Sardesai |
| Address |
Department of ENT-Head and Neck Surgery, Kasturba Medical College, Manipal |
| 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 |
| Ishan Sardesai |
Kasturba Medical College |
Department of ENT, 4th floor OPD Building, KMC Manipal
Udupi
KARNATAKA |
0820-2922218
ishansardesai@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Manipal |
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 |
| Comparator Agent |
Conventional septoturbinoplasty |
Conventional SURGICAL technique of performing procedure of septoturbinoplasty. Dose, frequency, route of administration and duration is NOT APPLICABLE |
| Intervention |
Endoscopic septoturbinoplasty |
Endoscopic SURICAL technique of performing procedure of septoturbinoplasty. Dose, frequency, route of administration and duration is NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptomatic deviated nasal septum, anterior as well as posterior deviation of septum, with no radiographic evidence of sinusitis, with associated allergic rhinitis adequately controlled by medical management, with associated turbinate hypertrophy |
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age, patients with mild asymptomatic deviated nasal septum, with sinus disease involving 2 or more paranasal sinuses, with radiographic evidence of sinusitis, with caudal dislocation of septum, undergoing revision surgery, with vasomotor rhinitis and nasal polyps, with allergic rhinitis not adequately controlled by medical management, those undergoing septorhinoplasty |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of nasal symptoms following septoturbinoplasty based on subjective NOSE questionnaire data collected pre and post operatively and data collected through diagnostic nasal endoscopy, pre and post operatively, analysed using Lund-Kennedy scoring system. |
Follow up period of each study subject will be 1 and 3 months (as per standard of care). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| % of intraoperative and postoperative complications in endoscopic versus conventional septoturbinoplasty groups |
Follow up period of each study subject will be 1 and 3 months (as per standard of care) |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
14/01/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, observational cohort study in which efficacy of endoscopic and conventional techniques of septoturbinoplasty will be compared. This will be done using subjective data through administration of NOSE questionnaire to patients pre and post operatively as well as objective data through diagnostic nasal endoscopy. Total study period is 2 years. The study includes patients fulfilling criteria for patient selection. The type of surgery will be decided by the treating surgeon. The surgical procedure as well as investigations are as per standard care of treatment. Follow up visits for each patient is at 1 and 3 months as per standard care of treatment and not for sake of the study. Results will be analyzed using appropriate statistical methods. |