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Laser-Assisted Versus Conventional Fenestration in Endoscopic Stapes Surgery: A Randomized Controlled Trial

Laser-Assisted Versus Conventional Fenestration in Endoscopic Stapes Surgery: A Randomized Controlled Trial

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250801006
Enrollment
42
Registered
2025-08-01
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients who were diagnosed with otosclerosis with stapes fixation and aged between 18 and 70 years otosclerosis, endoscope ear surgery, stapedotomy, stapes

Interventions

A diode laser was used to cauterize the stapedial tendon and posterior crus and create a fenestra at the footplate,A scissors was used to cut the stapedial tendon and posterior crus, then a manual per
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
laser stapes surgery,conventional stapes surgery

Sponsors

FACULTY OF MEDICINE, PRINCE OF SONGKLA UNIVERSITY
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. A diagnosis of otosclerosis with stapes fixation 2. age between 18 and 70 years 3. documented history of progressive hearing loss with air-bone gap more than 25 dB across the 0.5-4 kHz frequency range, and absent stapedial reflexes 4. no preoperative complaints of taste disturbance or lingual numbness.

Exclusion criteria

Exclusion criteria: a history of revision surgery, loss to follow-up, abnormalities of the ossicular chain, concomitant chronic ear infection or retraction pocket, and external auditory canals with a diameter less than 4 mm, which could not accommodate the endoscope.

Design outcomes

Primary

MeasureTime frame
Hearing outcomes 2,6, and 12 months audiological assessement,postoperative complications 2, 6 and 12 months questionnaire and clinical assessment

Secondary

MeasureTime frame
taste dysturbance 2,6, and 12 months questionaire

Countries

Thailand

Contacts

Public ContactYUVATIYA PLODPAI

SONGKLANAGARIND HOSPITAL, PRINCE OF SONGKLA UNIVERSITY

yuva078@hotmail.com074451394

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026