Clinical Trials Directory

Trials / Completed

CompletedNCT07417007

Coblation and Traditional Adenoidectomy: A Comparative Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
128 (actual)
Sponsor
Medipol University · Academic / Other
Sex
All
Age
3 Years – 11 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECold Curettage AdenoidectomyAfter 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.
PROCEDURECoblation-Assisted AdenoidectomyThe 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.

Timeline

Start date
2024-08-01
Primary completion
2025-08-30
Completion
2025-10-01
First posted
2026-02-18
Last updated
2026-02-18

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07417007. Inclusion in this directory is not an endorsement.