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NCT03760341
Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients
NA trial testing adenoidectomy - cold method in Obstructive Sleep Apnea in 80 participants. Completed in 20 March 2019.
30 August 2018
Quick facts
| Lead sponsor | Rambam Health Care Campus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 October 2014 |
| Primary completion | 30 August 2018 |
| Estimated completion | 20 March 2019 |
Drugs / interventions tested
- adenoidectomy - cold method
- adenoidectomy - hot method
Conditions studied
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
- Adenoid; Growth — all drugs for Adenoid; Growth →
Sponsor
Rambam Health Care Campus — full company profile →
Who can join
Adults 1 to 15, any sex, with Obstructive Sleep Apnea or Adenoid; Growth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Adenoidectomy is one of the most common procedures done by the otolaryngologist. The procedure can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and post-operative outcomes. However, the long term clinical outcome in improving the sleep disorder symptoms was never compared between the two methods. Objective: To compare the advantages using the hot method compared to the cold method adenoidectomy in the long term follow up. Methods: A prospective, randomized, single blinded study of children undergoing adenoidectomy between the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques. The primary outcome was change of the Pediatric Sleep Questionnaire Score (PSQ) scores one month and one year after surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03760341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Rambam Health Care Campus trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03760341 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rambam Health Care Campus
- Last refreshed: 17 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03760341.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing