NCT07457619

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

tonsillectomycoblationcold dissection

Outcome Measures

Primary Outcomes (2)

  • Rate of Secondary infection

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

    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

    one week

Study Arms (2)

coblation tonsillectomy

EXPERIMENTAL
Procedure: coblation tonsillectomy

cold dissection tonsillectomy

ACTIVE COMPARATOR
Procedure: cold dissection tonsillectomy

Interventions

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.

coblation tonsillectomy

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

cold dissection tonsillectomy

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital, Lahore

Bahawalpur, Pakistan

Location

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 9, 2026

Study Start

November 20, 2025

Primary Completion

February 19, 2026

Study Completion

February 19, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations