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Ear surgery with Teflon and fluoroplastic pistons

Endoscopic Stapedotomy with Fluoroplastic and Titanium Pistons - A Randomized control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030867
Enrollment
50
Registered
2021-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H758- Other specified disorders of middle ear and mastoid in diseases classified elsewhere Health Condition 2: H809- Unspecified otosclerosis

Interventions

Intervention1: Endoscopic Stapedotomy with fluoroplastic piston: Fluoroplastic piston inserted after endoscopic stapedotomy done under LA. Procedure time approximately 1 to 1.5 hrs Control Interventio

Sponsors

Intra mural Fund Comittee JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Air bone gap of atleast 15 db Type A or As Tympanogram diagnosed Stapes fixation intra-operatively

Exclusion criteria

Exclusion criteria: Only hearing ear, revision stapes surgery, active disease, and external or middle ear infection, debilitating medical illness.

Design outcomes

Primary

MeasureTime frame
The post operative Air-Bone gap and ABG closure is measured Timepoint: at 0, 1 and 3 months postoperatively—

Secondary

MeasureTime frame
The ease of insertion of titanium or fluoroplastic piston is measured by a questionnaire filled by the operating surgeon regarding fit of piston, and effort grading by the surgeon and number of attempts made by the surgeon for piston insertionTimepoint: in the immediate post-operative period—

Countries

India

Contacts

Public ContactCHINTA SANGEETHA MAHALAKSHMI

JIPMER

gsivram@gmail.com9445210548

Outcome results

None listed

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