| CTRI Number |
CTRI/2024/03/064494 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| 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 clinical outcomes of adenoidectomy using 2 methods: Microdebrider and Curette |
|
Scientific Title of Study
|
A Comparative study of clinical outcomes of adenoidectomy using Microdebrider versus Curette |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Suma |
| Designation |
Post graduate Student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Otorhinolaryngology, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8762539230 |
| Fax |
|
| Email |
sumabalanarayana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravishankar C |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Otorhinolaryngology, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9448062045 |
| Fax |
|
| Email |
ravientbmc18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravishankar C |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Otorhinolaryngology, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9448062045 |
| Fax |
|
| Email |
ravientbmc18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
B Suma |
| Address |
Post graduate student, Department of Otorhinolaryngology, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore 560002 |
| 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 B Suma |
Bangalore Medical College and Research Institute |
Department of Otorhinolaryngology, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore
Bangalore
KARNATAKA |
8762539230
sumabalanarayana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
adenoidectomy using Adenoid Curette |
St Clair Thomson adenoid curette is used to perform
adenoidectomy. Under general anaesthesia and endoscopic visualization, Adenoidectomy will be performed by Curettage Technique. Hemostasis achieved by coblator. Subsequently, Post-procedure follow-up is to be carried out at 12 weeks. This includes Pure tone audiometry, Tympanogram, Otoendoscopy, Diagnostic Nasal Endoscopy |
| Intervention |
Adenoidectomy using microdebrider |
Adenoidectomy, is one of the most frequently performed childhood
surgical procedures indicated for nasal obstruction or chronic adenoiditis. Newer technique of
adenoidectomy using Endoscope (to visualize the surgical field) with microdebrider (to
excise the adenoids). It may offer better vision and control. Under general anaesthesia and endoscopic visualization, Adenoidectomy will be performed by Endoscopic Microdebrider Technique. Hemostasis achieved by coblator. Subsequently, Post-procedure follow-up is to be carried out at 12 weeks. This includes Pure tone audiometry, Tympanogram, Otoendoscopy, Diagnostic Nasal Endoscopy
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Patients belonging to age group of 3-30 years.
2. Patients with clinical features of adenoid hypertrophy and indicated for
adenoidectomy surgery.
3. Patients fit for surgery.
4. Patients/ patient’s attendants who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patients/ patient’s attendants who do not give valid informed and written
consent.
2. Patients with cleft palate/ craniofacial deformities
3. Patients with other causes of hearing loss |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in hearing thresholds from pre-intervention study levels measured in
dB HL, using pure tone audiometry. |
before surgery(baseline) and 12 weeks after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in tympanogram type: Type B or C to Type A.
2. Comparison of Otoendoscopy findings
3. Reduction in the size of Adenoids on diagnostic nasal endoscopy
|
Before surgery(baseline) & at 12 weeks after surgery |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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 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
|
|