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NCT03294421
Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy
NA trial testing combined access tympanomastoidectomy in Cholesteatoma in 64 participants. Status unknown.
7 May 2020
Quick facts
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 22 September 2017 |
| Primary completion | 7 May 2020 |
| Estimated completion | 31 August 2020 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- combined access tympanomastoidectomy
- standard closed tympanomastoidectomy
Conditions studied
- Cholesteatoma — all drugs for Cholesteatoma →
- Chronic Otitis Media — all drugs for Chronic Otitis Media →
Sponsor
Hospital de Clinicas de Porto Alegre
Who can join
Adults 5 to 90, any sex, with Cholesteatoma or Chronic Otitis Media. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic otitis media is a prevalent medical condition, leading to important impact in the lives of the individuals with this condition, and a great amount of patients may need surgical intervention. The main objectives of the surgery in these cases are to restore the anatomy of the middle ear, to improve hearing and to remove the infection to avoid further complications. Still, chronic otitis media with cholesteatoma presents high rates of recurrence and residual symptoms after surgery. The standard technique used for treatment of chronic otitis media is microsurgery. Nonetheless, with the development of new technologies that use endoscopy, it is now possible to use endoscopic surgery to improve the visualization of the cholesteatoma and ear structures by combining both techniques. This study will evaluate the efficacy of the combined access surgery technique, which is microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with cholesteatoma. Furthermore, the study aims to compare the results of the combined access technique and the standard technique by randomizing the patients in two groups: one group will receive tympanomastoidectomy by standard technique and the other group will receive combined technique.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03294421
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Related trials
Other recruiting trials for Cholesteatoma
Currently open trials in the same condition.
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Other Hospital de Clinicas de Porto Alegre trials
Trials by the same sponsor.
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- NCT06953128 — General Versus Regional Anesthesia in Peripheral Arterial Surgery · NA · not yet recruiting
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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 NCT03294421 (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 Hospital de Clinicas de Porto Alegre
- Last refreshed: 7 September 2020
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/NCT03294421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing