Chronic TonsillitisNCT06937762
Coblation Tonsillotomy Versus Radiofrequency and Cold Knife Dissection Tonsillectomy
A study testing Intra capsular coblation tonsillotomy, Extracapsular cold knife dissection tonsillectomy and Extra capsular Radiofrequency tonsillectomy in people with Chronic Tonsillitis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to assess and compare the outcomes between coblation intracapsular tonsillotomy versus extracapsular Radiofrequency and cold knife dissection tonsillectomy efficacy in managing patients requiring tonsil surgery as regards (time of operation, Intraoperative blood loss, postoperative pain, postoperative… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Chronic Tonsillitis
- What is being tested?
- Intra capsular coblation tonsillotomy, Extracapsular cold knife dissection tonsillectomy and Extra capsular Radiofrequency tonsillectomy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 15 Sep 2025
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Recurrent Acute tonsillitis Tonsillitis resulting in febrile convulsions Enlarged tonsils that cause upper airway obstruction, dysphagia, sleep disorders Chronic tonsillitis Chronic or recurrent tonsillitis in a streptococcal carrier not responding to beta-lactamase-resistant antibiotics
Who cannot join
- Patients with known bleeding disorders Acute infections of tonsil Contraindications for general anesthesia Anemia Patients unwilling or unable to give informed consent were excluded from this study patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracapsular Coblation Tonsillotomy Versus Extracapsular Radiofrequency and Cold Knife Dissection Tonsillectomy
This study aims to assess and compare the outcomes between coblation intracapsular tonsillotomy versus extracapsular Radiofrequency and cold knife dissection tonsillectomy efficacy in managing patients requiring tonsil surgery as regards (time of operation, Intraoperative blood loss, postoperative pain, postoperative bleeding, complications, tonsillar fossa healing)
- Conditions
- Chronic Tonsillitis
- Being tested
- Intra capsular coblation tonsillotomy, Extracapsular cold knife dissection tonsillectomy, Extra capsular Radiofrequency tonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra capsular coblation tonsillotomyDevice
Tonsils were dissected from the surface inward with the wand set at Coblate 7 setting. The wand skims the tonsil surface with continuous saline irrigation. Ablation was performed without penetrating the tonsillar capsule. Retraction of the tonsillar pillars is done to define the margins for near complete ablation. When the capsule is approached, the wand is turned down to Coblate 3 setting. Thin layer of tonsillar tissue is left to protect the capsule. Bleeding does not occur in most cases, but when it occurs, the wand was used in the Coagulate 5 setting for homeostasis
Extracapsular cold knife dissection tonsillectomyDevice
Begin by retracting the anterior tonsillar pillar to expose the tonsil, use a cold knife (scalpel or tonsil dissector) to make an incision along the anterior pillar near the mucosal margin of the tonsil, identify the plane between the tonsillar capsule and the underlying pharyngeal muscle, then carefully dissect the tonsil away from the surrounding tissues, following the plane to avoid trauma to the underlying structures, proceed from the superior pole of the tonsil to the inferior pole, ensuring that the entire tonsil is removed, use gauze or sponges to control minor bleeding during the procedure, for more significant bleeding, apply direct pressure or use ligatures and cold packs, achieve final hemostasis using absorbable sutures or electrocautery if needed
Extra capsular Radiofrequency tonsillectomyDevice
Radiofrequency bipolar forceps, connected to a radiofrequency apparatus model Ellman Surgitron 4 MHz (Ellman International, New York, USA) by which cutting and dissection with coagulation were done in the same time with minimal diffuse heating to the surrounding tissue. The power was adjusted to a power grade 40 in a bipolar mode.
| Study group | Role | What they receive |
|---|---|---|
| Intra capsular coblation tonsillotomy | Active comparator | Not described Receives: Device: Intra capsular coblation tonsillotomy |
| Extracapsular cold knife dissection tonsillectomy | Active comparator | Not described Receives: Device: Extracapsular cold knife dissection tonsillectomy |
| Extra capsular Radiofrequency tonsillectomy | Active comparator | Not described Receives: Device: Extra capsular Radiofrequency tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparision of the severity of postoperative pain between the three groups.
1- Postoperative pain will be assessed using visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain)
Measured: The first time on day 1, the second time on day 3 and third time on day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 Apr 2025
- Primary completion1 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdi Noaman Othman Orabi, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937762
- Sponsor's protocol ID
- KFSIRB200-561
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Metcalfe C, Muzaffar J, Daultrey C, Coulson C. Coblation tonsillectomy: a systematic review and descriptive analysis. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2637-2647. doi: 10.1007/s00405-017-4529-4. Epub 2017 Mar 18.
PubMed 28315933Liu Q, Zhang Y, Lyu Y. Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults. Am J Otolaryngol. 2021 Jan-Feb;42(1):102760. doi: 10.1016/j.amjoto.2020.102760. Epub 2020 Oct 18.
PubMed 33125902
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracapsular Coblation Tonsillotomy Versus Extracapsular Radiofrequency and Cold Knife Dissection Tonsillectomy
- ClinicalTrials.gov ID
- NCT06937762
- Acronym / sponsor ID
- KFSIRB200-561
- Conditions
- Chronic Tonsillitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 22 Apr 2025 (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.
This study aims to assess and compare the outcomes between coblation intracapsular tonsillotomy versus extracapsular Radiofrequency and cold knife dissection tonsillectomy efficacy in managing patients requiring tonsil surgery as regards (time of operation, Intraoperative blood loss, postoperative pain, postoperative bleeding, complications, tonsillar fossa healing)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra capsular coblation tonsillotomy | Active comparator | Device: Intra capsular coblation tonsillotomy |
| Extracapsular cold knife dissection tonsillectomy | Active comparator | Device: Extracapsular cold knife dissection tonsillectomy |
| Extra capsular Radiofrequency tonsillectomy | Active comparator | Device: Extra capsular Radiofrequency tonsillectomy |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Recurrent Acute tonsillitis Tonsillitis resulting in febrile convulsions Enlarged tonsils that cause upper airway obstruction, dysphagia, sleep disorders Chronic tonsillitis Chronic or recurrent tonsillitis in a streptococcal carrier not responding to beta-lactamase-resistant antibiotics
Key exclusion criteria (1 listed)
- Patients with known bleeding disorders Acute infections of tonsil Contraindications for general anesthesia Anemia Patients unwilling or unable to give informed consent were excluded from this study patients
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 |
|---|---|---|
| Intra capsular coblation tonsillotomyTonsils were dissected from the surface inward with the wand set at Coblate 7 setting. The wand skims the tonsil surface with continuous saline irrigation. Ablation was performed without penetrating the tonsillar capsule. Retraction of the tonsillar pillars is done to define the margins for near complete ablation. When the capsule is approached, the wand is turned down to Coblate 3 setting. Thin layer of tonsillar tissue is left to protect the capsule. Bleeding does not occur in most cases, but when it occurs, the wand was used in the Coagulate 5 setting for homeostasis | Device | Intra capsular coblation tonsillotomy |
| Extracapsular cold knife dissection tonsillectomyBegin by retracting the anterior tonsillar pillar to expose the tonsil, use a cold knife (scalpel or tonsil dissector) to make an incision along the anterior pillar near the mucosal margin of the tonsil, identify the plane between the tonsillar capsule and the underlying pharyngeal muscle, then carefully dissect the tonsil away from the surrounding tissues, following the plane to avoid trauma to the underlying structures, proceed from the superior pole of the tonsil to the inferior pole, ensuring that the entire tonsil is removed, use gauze or sponges to control minor bleeding during the procedure, for more significant bleeding, apply direct pressure or use ligatures and cold packs, achieve final hemostasis using absorbable sutures or electrocautery if needed | Device | Extracapsular cold knife dissection tonsillectomy |
| Extra capsular Radiofrequency tonsillectomyRadiofrequency bipolar forceps, connected to a radiofrequency apparatus model Ellman Surgitron 4 MHz (Ellman International, New York, USA) by which cutting and dissection with coagulation were done in the same time with minimal diffuse heating to the surrounding tissue. The power was adjusted to a power grade 40 in a bipolar mode. | Device | Extra capsular Radiofrequency tonsillectomy |
Primary outcome
comparision of the severity of postoperative pain between the three groups.
Time frame: The first time on day 1, the second time on day 3 and third time on day 7
1- Postoperative pain will be assessed using visual analogue scale (VAS) from 0 (no pain) to 10 (worst 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 19 May 2026.
- Results publication: PubMed 28315933Metcalfe C, Muzaffar J, Daultrey C, Coulson C. Coblation tonsillectomy: a systematic review and descriptive analysis. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2637-2647. doi: 10.1007/s00405-017-4529-4. Epub 2017 Mar 18.
- Results publication: PubMed 33125902Liu Q, Zhang Y, Lyu Y. Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults. Am J Otolaryngol. 2021 Jan-Feb;42(1):102760. doi: 10.1016/j.amjoto.2020.102760. Epub 2020 Oct 18.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Tonsillitis
Not yet recruiting
Recovery From Tonsil Surgery.
Recurrent Tonsillitis, Chronic Tonsillitis
Active, not recruitingObservational study
A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes.
Chronic Tonsillitis
Active, not recruiting
Intracapsular Tonsillectomy in Adults
Tonsil Disease, Tonsillitis
Recruiting
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Tonsillitis Chronic, Tonsillitis Recurrent
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 Intra capsular coblation tonsillotomy, Extracapsular cold knife dissection tonsillectomy and Extra capsular Radiofrequency tonsillectomy in people with Chronic Tonsillitis, run by Kafrelsheikh University at 1 site in Egypt.
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 1 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 19 May 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 Egypt. 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?
comparision of the severity of postoperative pain between the three groups. (time frame: The first time on day 1, the second time on day 3 and third time on day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06937762, which also lists 2 linked publications.
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 19 May 2026.