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NCT Number: NCT07457619

Coblation Tonsillectomy Versus Cold Dissection Tonsillectomy

The surgical removal of the tonsils is known as a tonsillectomy. Even though tonsillectomy rates have decreased recently, it is still one of the most common surgical operations carried out globally.1 In 30 BC, Celsus was the first to describe tonsil removal. Since then, a variety of surgical techniques and better tools have been developed for this aim.2 Postoperative discomfort and hemorrhage are the two main postoperative consequences following tonsillectomy. The guillotine procedure, cold dissection, electrocautery, harmonic scalpel, coblation, and laser surgery are among the many tonsillectomy techniques used in the literature.3 Regarding the various surgical procedures, the most crucial factors in determining which approach is optimal for this treatment are increasing intra-operative efficiency and lowering post-operative morbidity. Pain and bleeding are two of the main postoperative problems that result from cold steel dissection tonsillectomy, which leaves the incision accessible for secondary intention healing.4,5 It is evident from literature review that hemorrhage is one of the major complication of tonsillectomy resulting in increased rate of morbidity and increase hospital stay. In 2001, coblation tonsillectomy was first offered as a safer and more efficient tonsil removal technique. By creating a plasma field at the probe's surface, this method ablates tissue at comparatively low temperatures (between 40 and 70 °C). Unlike diathermic coagulation, which produces temperatures beyond 500 °C, this plasma field, which is composed of highly ionized particles, analyzes and breaks down the molecular connections of confined tissue, greatly decreasing heat dissipation to neighboring tissues. In order to achieve hemostasis, the radiofrequency generator can also be utilized for coagulation.6,7 Given the advantages of a shorter operating time and less intraoperative hemorrhage, several institutions in our nation have already made the use of the more recent technique of coblation the normal practice. Since there isn't much information on the application of coblation in tonsillectomy procedures, The investigator chosen to compare the results of coblation and cold dissection tonsillectomy in the local community. In addition to being a valuable addition to the body of existing literature, this study will also offer local facts. Additionally, clinicians can receive empirical support for improved tonsillectomy technique to lower morbidity.

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Key information

Conditions

Tonsillitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaikh Zayed Hospital, Lahore

Bahawalpur, Pakistan

About this study

Study design: Randomized Controlled Trial Setting: Department of Otorhinolaryngology, Sheikh Zayed Hospital, Lahore. Sample size With a 95% confidence level, 80% study power, and a mean pain score of 1.84 ± 0.85 for the cold dissection group and 1.24 ± 0.77 for the coblation group, the sample size of 60 cases-30 in each group-is determined.8 Sampling Technique Non-probability, consecutive sampling.

DATA COLLECTION PROCEDURE:

A total of 60 patients admitted to the otorhinolaryngology department of Sheikh Zayed Hospital in Lahore will be chosen following approval by the CPSP and the institutional ethical review committee. Every patient will be asked for their informed permission. All demographic data, including age, gender, and length of illness, will then be recorded. Every chosen case will be given the opportunity to select a slip from the total number of mixed-up slips (half-slips will include the letter "A," and other half-slips will contain the letter "B"), and they will be assigned to the appropriate group. Patients in group A will have their tonsils removed by coblation, and those in group B will have their tonsils removed by cold dissection. With the help of the researcher, a single surgical team will do every procedure. Using curved Metzenbaum scissors to penetrate the peritonsillar area, blunt dissection to remove the tonsil from superior to inferior, and a wire snare to separate the inferior pole, a cold dissection tonsillectomy will be carried out. At a setting of 35, a bipolar cautery will be used to achieve hemostasis. Using subcapsular dissection along the tonsillar pillar mucosa, the EVAC70 T&A (ArthroCare ENT, Sunnyvale, CA) hand piece will execute the coblation-assisted tonsillectomy while preserving muscle. Hemostasis will be achieved on the coagulate 3 setting, and dissection will be performed on the coagulate 7 setting. All patients will receive the same anesthesia and recovery room procedures. As stated in the operational definition, postoperative pain score, primary, reactionary and secondary hemorrhage will be recorded. Pre-designed Performa will be used to gather the data (Annexure I).

DATA ANALYSIS:

SPSS version 25.0 will be used to enter and evaluate the data. The data's normality will be examined using the Shapiro-Wilk test. For age, duration of illness and postoperative pain score, the mean and SD or median (IQR) will be displayed. For gender, place of residence (rural vs. urban), primary, reactionary and secondary hemorrhage, frequency and percentage will be displayed. The independent "t" test will be used to compare the postoperative pain in both groups and chi square test for primary, reactionary and secondary hemorrhage; a p-value of less than 0.05 will be considered significant. Age, gender, length of illness, and residence (rural vs. urban) will all be stratified. The independent 't' test will be used after stratification, and a p-value of less than 0.05 will be regarded as significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with chronic tonsillitis (as per-operational definition) of duration >3 months

Exclusion criteria

  • History of peritonsillar abscess.
  • Patients with known bleeding disorder (INR >1.5).
  • Patients with tonsillar malignancy

Treatment and study plan

coblation tonsillectomy

Procedure

Using subcapsular dissection along the tonsillar pillar mucosa, the EVAC70 T&A (ArthroCare ENT, Sunnyvale, CA) hand piece will execute the coblation-assisted tonsillectomy while preserving muscle. Hemostasis will be achieved on the coagulate 3 setting, and dissection will be performed on the coagulate 7 setting.

cold dissection tonsillectomy

Procedure

Using curved Metzenbaum scissors to penetrate the peritonsillar area, blunt dissection to remove the tonsil from superior to inferior, and a wire snare to separate the inferior pole, a cold dissection tonsillectomy will be carried out. At a setting of 35, a bipolar cautery will be used to achieve hemostasis

Primary outcomes

  1. Rate of Secondary infection

    Time frame: 2 weeks

    presence of purulent discharge (thick and milky discharge from a wound) and resulting in opening of the skin wound

  2. Incidence of post-operative pain

    Time frame: one week

    measured using a visual analoque scale 7 days after the procedure, with 0 representing no pain and 10 representing the severe pain

Sponsors and collaborators

Lead sponsor

Shahida Islam Medical Complex

Other

Registry information

Official study title

Comparison of the Outcome of Coblation Tonsillectomy Versus Cold Dissection Tonsillectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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