| CTRI Number |
CTRI/2019/02/017492 [Registered on: 06/02/2019] Trial Registered Prospectively |
| Last Modified On: |
10/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Coblation adenotonsillectomy and conventional adenotonsillectomy |
|
Scientific Title of Study
|
A prospective randomized comparative study of coblation assisted adenotonsillectomy and conventional adenotonsillectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBkSIngh |
| Designation |
Senior Professor |
| Affiliation |
Jawahar Lal Nehru Medical College,Ajmer |
| Address |
Department Of Ent
Jawahar Lal Nehru Medical College,Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008315 |
| Fax |
|
| Email |
singhdrbk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBkSIngh |
| Designation |
Senior Professor |
| Affiliation |
Jawahar Lal Nehru Medical College,Ajmer |
| Address |
Department Of Ent
Jawahar Lal Nehru Medical College,Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008315 |
| Fax |
|
| Email |
singhdrbk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBkSIngh |
| Designation |
Senior Professor |
| Affiliation |
Jawahar Lal Nehru Medical College,Ajmer |
| Address |
Department of ent
Jawahar Lal Nehru Medical College,Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008315 |
| Fax |
|
| Email |
singhdrbk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Entomology,JLN Medical College,Ajmer |
|
|
Primary Sponsor
|
| Name |
Jawahar Lal Nehru Medical College Ajmer |
| Address |
Department Of Ent,Jawahar Lal Nehru Medical College,ajmer,rajasthan |
| 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 |
| DrRavikant Agrawal |
JLN MEDICAL COLLEGE,AJMER |
Department of ENT,JLN Medical college,Ajmer,Rajasthan
Ajmer
RAJASTHAN |
9887831776
aravikant62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jawahar Lal Nehru Medical College Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Adenotonsillectomy versus Coblation |
To compare intraoperative duration, bleeding and postoperative pain and time to return to normal activities. |
| Comparator Agent |
Conventional and Coblation Adenotonsillectomy |
To compare time and bleeding and postoperative pain |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Sore throats due to tonsillitis;
2.Five or more episodes of sore throat per year
3.Symptoms for at least a year;
4.Episodes of disabling sore throat which prevent normal functioning
5. Adenoid hypertrophy with upper airway obstruction
|
|
| ExclusionCriteria |
| Details |
1. Very young age under 4
2. Presence of acute infection
3. Refusal of surgery
4. Bleeding disorder
5. Unfit for surgery by anesthetic
|
|
|
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 |
1. The study aims to identify differences in time consumption during operation and amount of lost blood during operation
2. The study aims to identify immediate postoperative pain, postoperative haemorrhage whether primary or secondary and time needed to return back to the normal activity and diet.
|
DURATION OF STUDY IS AROUND ONE YEAR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.The study aims to identity postoperative pain. |
Duration of study is around 1year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2019 |
| Date of Study Completion (India) |
10/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1.The aim of study to identify differenance of time consumption and amount of bleeding loss during operation. 2.The study aim to identify immediate postoperative pain,postoperative hemmorahage wheather primary and secondary and time needed to return back to normal activity. |