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A study comparing ear surgery results in patients with and without eustachian tube opening treatment, using a sweet-tasting test to check tube function: A randomised trial

Comparative Outcomes of Tympanoplasty in Patients with Eustachian Tube Dilation vs. Without Eustachian Tube Dilation Using Saccharine test for Diagnosing Eustachian Tube Dysfunction: A Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091865
Enrollment
32
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: H720- Central perforation of tympanic membrane

Interventions

Intervention1: Eustachian tube dilation in patients undergoing tympanoplasty with eustachian tube dysfunction: eustachian tube is dilated using eustachian balloon catheter at 10 atm pressure for 2 min

Sponsors

All India Institute Of Medical Sciences Bathinda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged 18 to 50 years with a perforation of the tympanic membrane. Patients with eustachian tube dysfunction identified using saccharine test.

Exclusion criteria

Exclusion criteria: Patient refusal of consent Patients with chronic middle ear disease, cholesteatoma. Previous ear surgeries (except for minor procedures). eustachian tube defects due to anatomical abnormalities Patients with normal saccharine test time Patients with immunocompromised conditions- diabetic, hypertensive, HIV, autoimmune diseases. Patients with nasal pathologies ( polyps, afrs)

Design outcomes

Primary

MeasureTime frame
To determine graft uptake rates among patients with eustachian tube dysfunction who undergo eustachian tube dilatation and those who do not.Timepoint: To determine graft uptake rates with no residual perforation at 1 week, 1 month , 3 month and 6 month

Secondary

MeasureTime frame
To assess improvement in air bone gap closure in both groups. To assess complications postoperatively(e.g., recurrence of perforation, hearing loss) in both groups.Timepoint: improvement in air bone gap by performing pure tone audiometry at 1month, 3 month, 6 month. To assess complications postoperatively at day 1, 1week, 1 month, 3 month, 6 month.

Countries

India

Contacts

Public ContactDr Vaibhav Saini

All India Institute Of Medical Sciences Bathinda

drvaibhavsaini@gmail.com8872377681

Outcome results

None listed

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