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A trial which randomly assign patients needing stapes surgery to either endoscopic or microscopic procedures to see which one yields better results in terms of hearing improvement, complications, surgery duration, post-operative pain, and patient satisfaction

A Randomized Control Trial to compare the outcomes of endoscopic and microscopic stapes surgery - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/066041
Enrollment
50
Registered
2024-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: H743- Other acquired abnormalities of ear ossicles

Interventions

None listed

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are diagnosed with otosclerosis based on clinical history, examination and audiological assessment and opting for surgery. Patient with normal otoscopy findings Patient aged between 18 - 50 years Absent history of past middle ear infection diseases/past ear surgeries Patients undergoing stapes surgery under Local Anesthesia Only primary cases are included Patient willing to give written informed consent for surgery and to be part of the study

Exclusion criteria

Exclusion criteria: Patients with extreme of ages less than 18 years of age and greater than 50 years of age Patients with other causes of hearing loss. Patients with external ear and other middle ear pathologies. Patients with comorbidities deeming them unfit for local anesthesia

Design outcomes

Primary

MeasureTime frame
To compare the outcomes of endoscopic and microscopic stapes surgery in terms of post op hearing improvement. To compare the various intraoperative and postoperative complications of endoscopic and microscopic stapes surgery Timepoint: At pack removal (post op day 7), after 1 month and 3 months post surgery

Secondary

MeasureTime frame
To assess the visualization of various middle ear structures in order to understand the easiness of stapes surgery between endoscopic and microscopic stapes surgery in a trainee point of view.Timepoint: 1 day

Countries

India

Contacts

Public ContactThalhath A Salam

AIIMS New Delhi

winirk@hotmail.com9868397461

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026