Half-thickness Tragal Cartilage Graft vs Temporalis Fascia Graft Tympanoplasty Type I

NCT03817242 | Completed

• 1 other identifier: LadyRH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale of this study is to find out the surgical outcome and success rates of tragal cartilage and temporalis fascia, subsequently to develop guide line in light of the results of this study for our department as our institute is going to follow one patient in one bed policy in future. The purpose of this study is to compare the graft success rate of cartilage versus temporalis fascia in tympanoplasty type I in our institute, as no such study has been conducted in our province before.

Conditions

Hearing Loss,Conductive

Keywords

Cartilage; Hearing loss; Tympanoplasty

Outcome Measures

Primary Outcomes (1)

• Graft take up

  the graft take rate is determined in both the groups

  06 months of follow up

Secondary Outcomes (1)

• Objective change in hearing level

  03 months of follow up

Other Outcomes (1)

• Hearing satisfaction: whispering test

  05 months of follow up

Study Arms (2)

tympanoplasty with tragal cartilage

ACTIVE COMPARATOR

Tympanoplasty was performed using tragal cartilage graft

Procedure: Tympanoplasty using tragal cartilage graft

tympanoplasty with temporalis fascia

ACTIVE COMPARATOR

Tympanoplasty was performed using temporalis fascia graft

Procedure: Tympanoplasty using temporalis fascia graft

Interventions

Tympanoplasty using tragal cartilage graft PROCEDURE

tympanoplasty type I is performed using tragal cartilage in arm 1

tympanoplasty with tragal cartilage

Tympanoplasty using temporalis fascia graft PROCEDURE

tympanoplasty type I is performed using temporalis fascia in arm 2

tympanoplasty with temporalis fascia

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients of both genders in the age range 16 - 60 years.
• Inactive mucosal COM remained dry for at least one month.
• Conductive hearing loss with minimum air-bone gap (ABG) of 10 Decibel (dB).
• Middle ear is free of disease.

You may not qualify if:

• Attic and / or posterior retraction pocket with cholesteatoma.
• Ossicular chain dysfunction and associated otogenic complication.
• Active mucosal COM.

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead

Study Sites (1)

Fazali Wahid

Peshawar, Khyberpakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zahid Nazar

  Lady Reading Hospital, Peshawar, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Tympanoplasty I is performed in these patients in Group 1 tragal cartilage graft is used while in group 2 temporalis fascia graft is used

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 25, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: UPTO 5 YEARS
• Access Criteria: in 6 months and for 5 years

Locations

PA (1)