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Clinical Trials/CTRI/2023/09/057718
CTRI/2023/09/057718
Not yet recruiting
Phase 4

Comparison between coblation tonsillectomy and dissection tonsillectomy

Dr Sanjib Barman1 site in 1 country50 target enrollmentStarted: September 22, 2023Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Sanjib Barman
Enrollment
50
Locations
1
Primary Endpoint
To compare the efficacy of coblation tonsillectomy against dissection tonsillectomy in terms of operative duration, intraoperative blood loss, postoperative pain and postoperative hemorrhage

Overview

Brief Summary

Tonsillectomy is one ofthe most frequently carried out surgical operations worldwide. Numeroussurgical techniques have been recorded and various devices have been developedsince Celsus performed the first tonsillectomy in 30 B.c.

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

Cold dissectiontonsillectomy, also known as dissection tonsillectomy or cold knife techniquehas been the  standard procedure fordecades. Either the electrocautery or the ligation technique is used to achievethe surgical hemostasis. Recently, the new technology known as ‘Coblationtonsillectomy’ 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 bipolarelectrical current through a medium of normal saline to create a plasma fieldof highly ionized particles, which in turn breakdown intercellular bonds andmelt tissue at about 700C.There are two methods fordoing a coblation tonsillectomy: (1) Subtotal, intracapsular ablation, whichmay leave some tonsil tissue intact, and (2) Total, subcapsular tonsillectomy,which involves separating the entire tonsil from the surrounding pharyngealmuscle and tonsillar capsule.

Despite tonsillectomybeing the most common and simple surgery, the surgeon is constantly concernedabout the high risk of complications, including intra and post-operative haemorrhage, which can even result in shock and death. Because the oropharynx and tonsilshave an abundant blood supply, tonsillectomy carries a very high risk ofheamorrahge. Following a tonsillectomy, morbidity is significant. It includesboth perioperative and postoperative bleeding as well as postoperative pain.Dehydration and extended hospital stay come from the patient’s inability toreturn to a regular diet due to postoperative pain and difficulty inswallowing.The postoperative pain that might result in decreasedoral intake, dehydration, and prolonged reduction in daily activities is themost significant morbidity following adult tonsillectomy. Additionally, painthat limits pharyngeal muscle movement may decrease tonsillar fossa clearancewhich may lead to infection, which may then result in bleeding. It isbelieved that the muscle fibers (palatoglossal, palatopharyngeal, and superiorpharyngeal constrictor muscle) and nerve endings (Vagus and glossopharyngealnerves) around the tonsillar bed are damaged and exposed during tonsillectomysurgery, which causes pain. Because of this, it is thought that surgical methods that carefully preserve the peritonsillar plane and prevent harmto the underlying tissues can reduce postoperative pain.

Our study aims tomeasure the efficacy of coblation method of tonsillectomy against dissectionmethod in terms of operative time, intraoperative blood loss, postoperativepain and postoperative  heamorhage.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
10.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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
  • Hypertrophied tonsils causing difficulty in deglutition.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

To compare the efficacy of coblation tonsillectomy against dissection tonsillectomy in terms of operative duration, intraoperative blood loss, postoperative pain and postoperative hemorrhage

Time Frame: During operation,post operative day 1,3,5,7

Secondary Outcomes

  • To compare postoperative morbidity between coblation tonsillectomy and dissection tonsillectomy(Postoperative Day 1,3,5,7)

Investigators

Sponsor
Dr Sanjib Barman
Sponsor Class
Other [Self ]

Study Sites (1)

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