Coblation and Traditional Adenoidectomy: A Comparative Study

February 10, 2026 updated by: Lütfü Şeneldir, Medipol University

COMPARATIVE ANALYSIS OF COLD CURETTAGE AND COBLATION ADENOIDECTOMY: SURGICAL AND POSTOPERATIVE OUTCOMES WITH 0° AND 70° ENDOSCOPIC TECHNIQUES

Adenoidectomy is a common pediatric otolaryngologic procedure. While cold curettage remains widely practiced, endoscopic coblation has been developed to enhance precision, minimize intraoperative complications, and reduce residual tissue. This study compared outcomes of conventional cold curettage adenoidectomy and coblation-assisted adenoidectomy in pediatric patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 128 pediatric patients aged 3-11 years who underwent adenoidectomy between August 2024 and August 2025 was prospectively evaluated with a follow-up duration of 6-12 months. (Table 1) Of these, 64 underwent adenoidectomy and/or myringotomy with ventilation tube insertion using the conventional cold curettage method, while the remaining 64 underwent the same procedures using the endoscopic coblation technique with 0° or 70° endoscopes. All patients had been diagnosed with adenoid hypertrophy and were unresponsive to medical treatment. Indications for surgery included nasal obstruction and associated symptoms such as snoring, apnea, mouth breathing during sleep, recurrent otitis media, and hearing loss due to serous otitis media.

Exclusion criteria included patients who underwent concurrent tonsillectomy, dental procedures, or nasal surgeries such as septoplasty and/or turbinate reduction. Patients with chronic neurological disorders or cleft palate were also excluded. Informed consent was obtained from all participants prior to inclusion in the study.

All patients underwent a detailed anamnesis and clinical examination. Following the application of a nasal decongestant spray, nasal endoscopy was performed, and the size and position of the adenoid tissue were scored from 1 to 4 using the McMurray and Clemens scoring system.4 In patients who were uncooperative or for whom endoscopic examination could not be performed, lateral nasopharyngeal radiographs were taken to allow for grading. During the operation, the size and extent of the adenoid tissue were confirmed transnasally or transorally using 0° or 70° rigid endoscopes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bagcılar
      • Istanbul, Bagcılar, Turkey (Türkiye), 34214
        • Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Adenoid hypertrophy and were unresponsive to medical treatment. Indications for surgery included nasal obstruction and associated symptoms such as snoring, apnea, mouth breathing during sleep, recurrent otitis media, and hearing loss due to serous otitis media.

-

Exclusion Criteria: Exclusion criteria included patients who underwent concurrent tonsillectomy, dental procedures, or nasal surgeries such as septoplasty and/or turbinate reduction. Patients with chronic neurological disorders or cleft palate were also excluded

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cold Curettage Adenoidectomy
Conventional adenoidectomy performed using cold curettage technique.
Procedure: Cold Curettage Adenoidectomy
After achieving adequate exposure under general anesthesia using a Boyle-Davis mouth gag, the soft palate and adenoid tissue were manually palpated, and curettage was performed using a suitably sized adenotome. Residual tissue areas suspected upon digital palpation and laryngeal mirror examination were further curetted using a smaller adenotome.
Experimental: Coblation-Assisted Adenoidectomy
Endoscopic adenoidectomy performed using coblation technology.
Procedure: Coblation-Assisted Adenoidectomy
The nasopharynx and choanae were fully visualized using a 2.7 mm 0° pediatric transnasal endoscope and a 70° 4 mm transoral endoscope, then adenoidectomy was completed using a coblation technique. The procedure was performed using the Coblator II cold radiofrequency coblation device equipped with the PROcise XP plasma rod system, which can be shaped to reach all areas of the adenoid tissue (especially the upper part of the nasopharynx and the opening to the eustachian tubes) and is designed for soft tissue ablation and dissection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Residual Adenoid Tissue Rate
Time Frame: During the follow-up assessments at 1, 6, and 12 months postoperatively
Presence of residual adenoid tissue evaluated postoperatively.
During the follow-up assessments at 1, 6, and 12 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: During surgery
Duration of the surgical procedure.
During surgery
Intraoperative Complications
Time Frame: During Surgery
Occurrence of intraoperative complications such as bleeding or mucosal injury.
During Surgery
Intraoperative Blood Loss
Time Frame: During Surgery
The total blood loss was calculated by subtracting the amount of saline used from the total fluid volume in the suction canister and adding the estimated amount from the gauze.
During Surgery
Postoperative Pain
Time Frame: Post operative 24 hours and at the 72nd hour
Postoperative pain was assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain ever experienced). Parents were asked to rate their child's pain at the first 24 hours and at the 72nd hour based on their child's behavior such as crying and discomfort
Post operative 24 hours and at the 72nd hour
Halitosis
Time Frame: Postoperative two weeks
Postoperative halitosis was assessed based on parental observation. Parents were instructed to approach their child from a distance of approximately 10 cm and to record the presence or absence of unpleasant oral odor
Postoperative two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LÜTFÜ ŞENELDİR, Associate Professor, Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-10840098-202.3.02-5336

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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