- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417007
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bagcılar
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Istanbul, Bagcılar, Turkey (Türkiye), 34214
- Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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.
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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
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Study Plan
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 |
Intervention / Treatment |
|---|---|
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Experimental: Cold Curettage Adenoidectomy
Conventional adenoidectomy performed using cold curettage technique.
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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.
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Experimental: Coblation-Assisted Adenoidectomy
Endoscopic adenoidectomy performed using coblation technology.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Residual Adenoid Tissue Rate
Time Frame: During the follow-up assessments at 1, 6, and 12 months postoperatively
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Presence of residual adenoid tissue evaluated postoperatively.
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During the follow-up assessments at 1, 6, and 12 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Operative Time
Time Frame: During surgery
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Duration of the surgical procedure.
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During surgery
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Intraoperative Complications
Time Frame: During Surgery
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Occurrence of intraoperative complications such as bleeding or mucosal injury.
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During Surgery
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Intraoperative Blood Loss
Time Frame: During Surgery
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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.
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During Surgery
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Postoperative Pain
Time Frame: Post operative 24 hours and at the 72nd hour
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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
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Post operative 24 hours and at the 72nd hour
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Halitosis
Time Frame: Postoperative two weeks
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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
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Postoperative two weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: LÜTFÜ ŞENELDİR, Associate Professor, Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-5336
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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