| 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
|
|
|
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
|
|
|
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. |