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Comparison of different graft materials in Endoscopic Tympanoplasty.

A comparative study of endoscopic tympanoplasty cartilage vs temporalis fascia graft in chronic otitis media with inactive mucosal disease. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076404
Enrollment
100
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: H653- Chronic mucoid otitis media

Interventions

Intervention1: Temporalis Fascia graft : In Endoscopic Tympanoplasty use of patients own temporalis fascia graft. Frequency- 1 Fascia per patient per surgery. Time taken- 1-2 hours. Control Interventi

Sponsors

Dr Arunabha Sengupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with chronic otitis media (inactive mucosal variety) 2.Patient having dry TM perforation for at least 6 weeks 3.Pure conductive hearing loss, intact ossicular chain found pre operative and per operative. 4.Patient with good cochlear reserve 5.Patients with healthy middle ear mucosa 5.All patients must be willing to take part in the study through written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with Drug allergies and known end organ damage i.e. Cerebrovascular diseases, cardiovascular system disorder, chronic obstructive lung disease, coagulation defect, hepatic or renal failure, malignancy and other debilitating disease 2.Patients with deformity of external auditory meatus, very narrow External auditory canal. 3.Presence of Sensorineural hearing loss 4.Patient not willing to participate 5.Patients unfit for surgery or anesthesia.

Design outcomes

Primary

MeasureTime frame
comparison of graft uptake.Timepoint: 1 month 3 months 6 months

Secondary

MeasureTime frame
comparison of hearing outcome.Timepoint: 1 month 3 months 6 months

Countries

India

Contacts

Public ContactArunabha Sengupta

Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital

arunabhasengupta@gmail.com9831089737

Outcome results

None listed

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