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A clinical trial to compare the results of two techniques (single and double flap technique) of endoscopic tympanoplasty - an ear surgery.

Endoscopic Single Flap versus Double Flap Tympanoplasty: a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038620
Enrollment
40
Registered
2021-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Endoscopic Double tympanomeatal flap tympanoplasty: •Posterior tympanomeatal flap will be elevated like, in group A. •Then, the anterior tympanomeatal flap will be elevated by giving a

Sponsors

Maulana Azad Medical College and associated Lok Nayak Hospital GIPMER GNEC New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age group >18 years & = 60 years 2.Grade III and Grade IV tympanic membrane perforations. 3.Dry ear 4.Good cochlear reserve

Exclusion criteria

Exclusion criteria: 1.Active mucosal disease 2.Atticoantral disease 3.Revision ear surgery 4.Active nasopharynx or sinus infection 5.Extensive tympanosclerosis 6.Suspected ossicular involvement

Design outcomes

Primary

MeasureTime frame
Graft uptake rate at 3 months after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.Timepoint: 3 months after the intervention (surgery)

Secondary

MeasureTime frame
Change in air conduction- bone conduction gap (AB gap) after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.Timepoint: 3 months after the intervention(surgery)

Countries

India

Contacts

Public ContactShafaat Ahmad

Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi

ravimeher@gmail.com091-9968894343

Outcome results

None listed

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