Endoscopic Coblation AdenoidectomyNCT07417007
Coblation and Traditional Adenoidectomy: A Comparative Study
A study testing Cold Curettage Adenoidectomy and Coblation-Assisted Adenoidectomy in people with Endoscopic Coblation Adenoidectomy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Endoscopic Coblation Adenoidectomy
- What is being tested?
- Cold Curettage Adenoidectomy and Coblation-Assisted Adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Oct 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 11 years
- All sexes
- No healthy volunteers
- Child
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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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.
Istanbul, Bagcılar, 34214
About this study
Official title: 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.
Read the 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
- Endoscopic Coblation Adenoidectomy
- Being tested
- Cold Curettage Adenoidectomy, Coblation-Assisted Adenoidectomy
- Keywords
- Adenoidectomy; Coblation; Cold curettage; Pediatric otolaryngology; Residual adenoid tissue; Postoperative pain; Halitosis; Intraoperative blood loss
- Medical subject headings
- Pain, Postoperative, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Curettage AdenoidectomyProcedure or surgery
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.
Coblation-Assisted AdenoidectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Curettage Adenoidectomy | Experimental | Conventional adenoidectomy performed using cold curettage technique. Receives: Procedure: Cold Curettage Adenoidectomy |
| Coblation-Assisted Adenoidectomy | Experimental | Endoscopic adenoidectomy performed using coblation technology. Receives: Procedure: Coblation-Assisted Adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Adenoid Tissue Rate
Presence of residual adenoid tissue evaluated postoperatively.
Measured: During the follow-up assessments at 1, 6, and 12 months postoperatively
Secondary outcomes (5)
Operative Time
Duration of the surgical procedure.
Measured: During surgery
Intraoperative Complications
Occurrence of intraoperative complications such as bleeding or mucosal injury.
Measured: During Surgery
Intraoperative Blood Loss
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.
Measured: During Surgery
Postoperative Pain
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
Measured: Post operative 24 hours and at the 72nd hour
Halitosis
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
Measured: Postoperative two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Aug 2024
- Primary completion30 Aug 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Coblation AdenoidectomyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two different surgeries; Conventional cold curettage adenoidectomy Coblation-assisted adenoidectomy
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lütfü Şeneldir, Medipol University
- Investigators
- LÜTFÜ ŞENELDİR, Associate Professor, Principal investigator, Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417007
- Sponsor's protocol ID
- E-10840098-202.3.02-5336
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seneldir L, Dogan VPA. Comparative analysis of cold curettage and coblation adenoidectomy: surgical and postoperative outcomes with 0 degrees and 70 degrees endoscopic techniques. BMC Surg. 2026 May 23;26(1):535. doi: 10.1186/s12893-026-03831-1.
PubMed 42174589
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE ANALYSIS OF COLD CURETTAGE AND COBLATION ADENOIDECTOMY: SURGICAL AND POSTOPERATIVE OUTCOMES WITH 0° AND 70° ENDOSCOPIC TECHNIQUES
- ClinicalTrials.gov ID
- NCT07417007
- Acronym / sponsor ID
- E-10840098-202.3.02-5336
- Conditions
- Endoscopic Coblation Adenoidectomy
- Keywords
- Adenoidectomy; Coblation; Cold curettage; Pediatric otolaryngology; Residual adenoid tissue; Postoperative pain; Halitosis; Intraoperative blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 18 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two different surgeries; Conventional cold curettage adenoidectomy Coblation-assisted adenoidectomy
| Arm | Type | Receives |
|---|---|---|
| Cold Curettage Adenoidectomy | Experimental | Procedure: Cold Curettage AdenoidectomyConventional adenoidectomy performed using cold curettage technique. |
| Coblation-Assisted Adenoidectomy | Experimental | Procedure: Coblation-Assisted AdenoidectomyEndoscopic adenoidectomy performed using coblation technology. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Cold 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. | Procedure or surgery | Cold Curettage Adenoidectomy |
| Coblation-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. | Procedure or surgery | Coblation-Assisted Adenoidectomy |
Primary outcome
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.
5 secondary outcomes
Operative Time
Time frame: During surgery
Intraoperative Complications
Time frame: During Surgery
Intraoperative Blood Loss
Time frame: During Surgery
Postoperative Pain
Time frame: Post operative 24 hours and at the 72nd hour
Halitosis
Time frame: Postoperative two weeks
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 18 Feb 2026.
- Derived from this study: PubMed 42174589Seneldir L, Dogan VPA. Comparative analysis of cold curettage and coblation adenoidectomy: surgical and postoperative outcomes with 0 degrees and 70 degrees endoscopic techniques. BMC Surg. 2026 May 23;26(1):535. doi: 10.1186/s12893-026-03831-1.
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.
LÜTFÜ ŞENELDİR, Associate Professor principal investigator
Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, İstanbul Medipol University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Curettage Adenoidectomy and Coblation-Assisted Adenoidectomy in people with Endoscopic Coblation Adenoidectomy, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Feb 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 Turkey (Türkiye). 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?
Residual Adenoid Tissue Rate (time frame: During the follow-up assessments at 1, 6, and 12 months postoperatively). 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 NCT07417007, which also lists 1 linked publication.
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 18 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.