TonsillitisNCT07457619
Coblation Tonsillectomy Versus Cold Dissection Tonsillectomy
A study testing coblation tonsillectomy and cold dissection tonsillectomy in people with Tonsillitis, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- coblation tonsillectomy and cold dissection tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2025to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients with chronic tonsillitis (as per-operational definition) of duration >3 months
Who cannot join
- History of peritonsillar abscess.
- Patients with known bleeding disorder (INR >1.5).
- Patients with tonsillar malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Outcome of 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.
Read the detailed description
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.
- Conditions
- Tonsillitis
- Being tested
- coblation tonsillectomy, cold dissection tonsillectomy
- Keywords
- tonsillectomy, coblation, cold dissection
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coblation tonsillectomyProcedure or surgery
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 tonsillectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| coblation tonsillectomy | Experimental | Not described Receives: Procedure: coblation tonsillectomy |
| cold dissection tonsillectomy | Active comparator | Not described Receives: Procedure: cold dissection tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Secondary infection
presence of purulent discharge (thick and milky discharge from a wound) and resulting in opening of the skin wound
Measured: 2 weeks
Incidence of post-operative pain
measured using a visual analoque scale 7 days after the procedure, with 0 representing no pain and 10 representing the severe pain
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start20 Nov 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457619
- Sponsor's protocol ID
- SZH, Lahore
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcome of Coblation Tonsillectomy Versus Cold Dissection Tonsillectomy
- ClinicalTrials.gov ID
- NCT07457619
- Acronym / sponsor ID
- SZH, Lahore
- Conditions
- Tonsillitis
- Keywords
- tonsillectomy, coblation, cold dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coblation tonsillectomy | Experimental | Procedure: coblation tonsillectomy |
| cold dissection tonsillectomy | Active comparator | Procedure: cold dissection tonsillectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients with chronic tonsillitis (as per-operational definition) of duration >3 months
Key exclusion criteria (3 listed)
- History of peritonsillar abscess.
- Patients with known bleeding disorder (INR >1.5).
- Patients with tonsillar malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coblation tonsillectomyUsing 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. | Procedure or surgery | coblation tonsillectomy |
| cold dissection tonsillectomyUsing 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 | Procedure or surgery | cold dissection tonsillectomy |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Tonsillitis
Not yet recruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
Recruiting
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Peritonsillar Abscess, Peritonsillar Cellulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coblation tonsillectomy and cold dissection tonsillectomy in people with Tonsillitis, run by Shahida Islam Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Secondary infection (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.