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CTRI Number  CTRI/2023/09/057718 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 12/09/2023
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 tonsil operation between two techniques: coblation technique and dissection technique  
Scientific Title of Study   Comparison between coblation tonsillectomy and dissection 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 Sanjib Barman  
Designation  Post graduate trainee 
Affiliation  Silchar Medical College and Hospital  
Address  Department of otorhinolaryngology, Silchar Medical College and Hospital,Ghungoor,Silchar,Cachar

Cachar
ASSAM
788014
India 
Phone  8638094036  
Fax    
Email  sanjibbarman0786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smrity Rupa Borah Dutta 
Designation  Professor and Head of the Department  
Affiliation  Silchar Medical College and Hospital  
Address  Department of otorhinolaryngology, Silchar Medical College and Hospital,Ghungoor,Silchar,Cachar

Cachar
ASSAM
788014
India 
Phone  9435348294  
Fax    
Email  smritylana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smrity Rupa Borah Dutta 
Designation  Professor and Head of the Department  
Affiliation  Silchar Medical College and Hospital  
Address  Department of otorhinolaryngology, Silchar Medical College and Hospital,Ghungoor,Silchar,Cachar

Cachar
ASSAM
788014
India 
Phone  9435348294  
Fax    
Email  smritylana@gmail.com  
 
Source of Monetary or Material Support  
Silchar Medical College and Hospital, Ghungoor,Silchar,Cachar,Assam,788014 
 
Primary Sponsor  
Name  Dr Sanjib Barman  
Address  Department of otorhinolaryngology,Silchar Medical College and Hospital,Ghungoor,Silchar, Cachar,Assam, Pin-788014 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjib Barman   Silchar Medical College and Hospital   Department of Otorhinolaryngology
Cachar
ASSAM 
8638094036

sanjibbarman0786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Silchar Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coblation Tonsillectomy   Coblation technique uses a specially designed probe which both coagulates and cuts the tissues.This technology utilizes a system of radiofrequency bipolar electrical current that passes through a medium of sodium ions.These energized ions are able to breakdown intercellular bonds and effectively vaporize tissue at a temperature of only 60 degree celcius. The coblator consists of a hand piece with a suction irrigation tip that transmit the radiofrequency current and dissects tissue and also a cautery capability for hemostasis. 
Comparator Agent  Dissection tonsillectomy   Tonsillectomy is done by cutting the pharyngeal mucosa with scissors, then dissection of the Tonsil from the lateral pharyngeal wall using Mollison tonsillar dissector and pillar retractor.Haemostasis is achieved with either ligatures(ties) or by using electrocautery. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients of age between 10 and 50 years
2.Patients full filling paradise criteria for tonsillectomy(episodes of sore throat)
-7 or more episodes in the preceding year,
-5 or more episodes in each of the preceding 2 year
-3 or more episodes in each of the preceding 3 year
3. Hypertrophied tonsils causing difficulty in deglutition 
 
ExclusionCriteria 
Details  1.Patients of age less than 10 years and more than 50 years
2.Pregnancy and lactation
3.Patients having bleeding diathesis , poor anesthetic risk or uncontrolled medical illness, anemia, and acute infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of coblation tonsillectomy against dissection tonsillectomy in terms of operative duration, intraoperative blood loss, postoperative pain and postoperative hemorrhage   During operation,post operative day 1,3,5,7 
 
Secondary Outcome  
Outcome  TimePoints 
To compare postoperative morbidity between coblation tonsillectomy and dissection tonsillectomy   Postoperative Day 1,3,5,7 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   22/09/2023 
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="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  

Tonsillectomy is one of the most frequently carried out surgical operations worldwide. Numerous surgical techniques have been recorded and various devices have been developed since Celsus performed the first tonsillectomy in 30 B.c.

The literature describes a variety of tonsillectomy techniques. These include cryosurgery , guillotine, dissection, suction diathermy, bipolar scissor dissection, monopolar and bipolar diathermy dissection, ultrasonic removal, radiofrequency and laser surgery. Any enhancement of these techniques should result in a reduction in operating time, a decrease in intraoperative and postoperative blood loss, and a decrease in postoperative morbidity.

Cold dissection tonsillectomy, also known as dissection tonsillectomy or cold knife technique has been the  standard procedure for decades. Either the electrocautery or the ligation technique is used to achieve the surgical hemostasis. Recently, the new technology known as ‘Coblation tonsillectomy’ has come to light as a potentially appealing option for this procedure. In contrast to electrocautery which cuts tissue at 4000C, Coblation  involves passing a radiofrequency bipolar electrical current through a medium of normal saline to create a plasma field of highly ionized particles, which in turn breakdown intercellular bonds and melt tissue at about 700C. There are two methods for doing a coblation tonsillectomy: (1) Subtotal, intracapsular ablation, which may leave some tonsil tissue intact, and (2) Total, subcapsular tonsillectomy, which involves separating the entire tonsil from the surrounding pharyngeal muscle and tonsillar capsule. 

Despite tonsillectomy being the most common and simple surgery, the surgeon is constantly concerned about the high risk of complications, including intra and post-operative haemorrhage, which can even result in shock and death. Because the oropharynx and tonsils have an abundant blood supply, tonsillectomy carries a very high risk of heamorrahge. Following a tonsillectomy, morbidity is significant. It includes both perioperative and postoperative bleeding as well as postoperative pain. Dehydration and extended hospital stay come from the patient’s inability to return to a regular diet due to postoperative pain and difficulty in swallowing.The postoperative pain that might result in decreased oral intake, dehydration, and prolonged reduction in daily activities is the most significant morbidity following adult tonsillectomy. Additionally, pain that limits pharyngeal muscle movement may decrease tonsillar fossa clearance which may lead to infection, which may then result in bleeding. It is believed that the muscle fibers (palatoglossal, palatopharyngeal, and superior pharyngeal constrictor muscle) and nerve endings (Vagus and glossopharyngeal nerves) around the tonsillar bed are damaged and exposed during tonsillectomy surgery, which causes pain. Because of this, it is thought that surgical methods that carefully preserve the peritonsillar plane and prevent harm to the underlying tissues can reduce postoperative pain.

Our study aims to measure the efficacy of coblation method of tonsillectomy against dissection method in terms of operative time, intraoperative blood loss, postoperative pain and postoperative  heamorhage.

 
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