| CTRI Number |
CTRI/2020/02/023119 [Registered on: 05/02/2020] Trial Registered Prospectively |
| Last Modified On: |
04/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of a newer method of removal of tonsil with an instrument called coblator with the older conventional method of removal of tonsil - a randomised controlled trial |
|
Scientific Title of Study
|
Comparison of coblation versus conventional tonsillectomy - a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Sheetal |
| Designation |
Assistant professor |
| Affiliation |
Karpaga Vinayaga Institute of medical sciences and research centre |
| Address |
GST Road, Chinna Kolambakkam, Palayanoor dist, Maduranthakam, Tamil nadu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
|
| Fax |
|
| Email |
sheetal86k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G N Nikisha |
| Designation |
Junior Resident |
| Affiliation |
Karpaga Vinayaga Institute of medical sciences and research centre |
| Address |
GST Road, Chinna Kolambakkam, Palayanoor dist, Maduranthakam, Tamil nadu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9445378910 |
| Fax |
|
| Email |
nikimol@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr G N Nikisha |
| Designation |
Junior Resident |
| Affiliation |
Karpaga Vinayaga Institute of medical sciences and research centre |
| Address |
GST Road, Chinna Kolambakkam, Palayanoor dist, Maduranthakam, Tamil nadu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9445378910 |
| Fax |
|
| Email |
nikimol@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of medical sciences and search centre |
|
|
Primary Sponsor
|
| Name |
Karpaga Vinayaga institute of medical sciences and research centre |
| Address |
GST Road, Chinnakolambakkam, Maduranthakam, Palayanoor post, Tamil Nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 G N Nikisha |
Karpaga Vinayaga Institute of medical sciences and research centre |
GST Road, Chinna Kolambakkam, Palayanoor dist, Maduranthakam, Tamil nadu
Kancheepuram
TAMIL NADU |
9445378910
nikimol@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J351||Hypertrophy of tonsils, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coblation tonsillectomy |
Tonsillectomy using coblator |
| Comparator Agent |
Conventional tonsillectomy |
Tonsillectomy using dissection and snare method |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Chronic tonsillitis
Recurrent tonsillitis
Obstructive sleep apnoea |
|
| ExclusionCriteria |
| Details |
Acute infection
Peritonsillar abscess
Bleeding and clotting disorders
Cervical spine pathology |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative blood loss, operative time, complications, post operative pain, patient satisfaction |
POD 0, 3, 7, 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative healing, patient satisfaction |
Day 14 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/02/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomised controlled study comparing coblation tonsillectomy with conventional tonsillectomy. Here we compare the newer method of tonsillectomy with older method to find the advantages and disadvantages of the newer method and overall complication rate and patient satisfaction of the newer method. |