| CTRI Number |
CTRI/2024/04/066509 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the outcomes of different surgical techniques in patient undergoing tonsillectomy |
|
Scientific Title of Study
|
Comparison of surgical outcomes of cold dissection, coblation and CO2 laser in patients undergoing tonsillectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lanu Anuta Aimol |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no. 408, ENT Department, 4th floor, Block 4A, OPD building, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7662008834 |
| Fax |
|
| Email |
lanuanuta95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikram Choudhury |
| Designation |
Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no. 409, ENT department, 4th floor, Block 4A, OPD building, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7976856497 |
| Fax |
|
| Email |
comatosebuddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bikram Choudhury |
| Designation |
Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no. 409, ENT department, 4th floor, Block 4A, OPD building, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7976856497 |
| Fax |
|
| Email |
comatosebuddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan, India 342005 |
|
|
Primary Sponsor
|
| Name |
Dr Lanu Anuta Aimol |
| Address |
Room no. 408, ENT Department, 4th floor, Block 4A, OPD building, AIIMS Jodhpur, Rajasthan, India 342005 |
| 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 Lanu Anuta Aimol |
AIIMS Jodhpur |
Room no. 408, ENT Department, 4th floor, Block 4A, OPD building, M.I.A. 1st Phase, Basni, AIIMS Jodhpur
Jodhpur
RAJASTHAN |
766008834
lanuanuta95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trails) AIIMS Jodhpur |
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 |
| Comparator Agent |
Tonsillectomy |
Tonsillectomy by cold dissection, coblation or CO2 laser |
| Intervention |
Tonsillectomy by CO2 laser |
Using CO2 laser for 1 hour |
| Intervention |
Tonsillectomy by coblation |
By MLW wand for 30 minutes |
| Intervention |
Tonsillectomy by cold dissection |
By Cold steel using Eve’s tonsillar snare for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Any patients undergoing tonsillectomy |
|
| ExclusionCriteria |
| Details |
Patients with bleeding diathesis, anaemia, Oropharyngeal Squamous Cell Carcinoma and patients not consenting for surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-Operative Pain |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intra-Operative and Post-Operative bleeding
2. Complications |
1. 2 years
2. 2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aims and Objectives: To study and compare the surgical outcomes of Cold Dissection, Coblation and CO2 Laser in patients undergoing tonsillectomy. Objectives: 1. To assess the outcomes of tonsillectomy by cold dissection, CO2 laser and coblation method. 2.To compare the surgical outcomes for pain, bleeding and complications.
Detailed methodology: - A Randomised Controlled Trial is planned for comparing surgical outcomes of cold dissection, coblation and CO2 laser in patients undergoing tonsillectomy in the Department of Otorhinolaryngology, AIIMS, Jodhpur.
- Patients will be subjected to surgery as per Pre-op protocol and discussion.
- Randomisation will be done using envelopes which contain the name of the arm under which the patient will be included (single blinded).
- Patients undergoing tonsillectomy will be divided into three random groups and different techniques (Cold Dissection, Coblation, CO2 Laser ) will be used.
- Intra operative bleeding will be noted based on anaesthesiologist’s documentation which includes soakage of gauge pieces and blood collected in suction apparatus as per our form.
- The surgical outcomes of these techniques will be evaluated postoperatively for pain, bleeding and complications till 3 months.
- Post operative pain will be assessed on day 1, 3, 7 and 14 with the help of VAS (Visual Analogue Scale, Faces Rating Scale)
- The patient will be assessed post operatively for status of tonsillar fossa- healthy/unhealthy.
|