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

Comparison of Half-thickness Tragal Cartilage Graft to Temporalis Fascia Graft

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss,Conductive
• Intervention / Treatment: Procedure: Tympanoplasty using tragal cartilage graft; Procedure: Tympanoplasty using temporalis fascia graft

Detailed Description

Tympanic membrane is forming lateral wall of the middle ear cleft which separates middle ear from the external auditory canal. It is made of three layers except in the upper part (Pars Flaccida). The outer layer of TM (Tympanic Membrane) is made of epithelium; middle layer is fibrous tissue, while inner layer is mucosal lining. The thickness of TM measures 0.1 mm, having diameter of 7-10 mm, weighing approximately 14 mg. The function of TM is to assist in hearing and protection of middle ear from infection. Perforation in tympanic membrane is the loss in continuity of TM layers. The causes of TM perforation may be trauma like blast, accident and firearm or infection of the middle ear like acute or chronic suppurative otitis media. It can also be iatrogenic as in case of placement of grommet for glue ear. The purpose of Tympanoplasty is to reconstruct TM perforation and restores sound conducting mechanism. In 1955, Zoellner and Wullstein used different types of graft materials for tympanoplasty. Later Heermann introduced cartilage palisade graft labeled as Simmering Technique. Similarly Goodhill also introduced first cartilage perichondrium composite graft material. Different graft materials can be used to close the TM defect. Some of these materials are temporalis fascia, tragal cartilage, perichondrium and fat. Temporalis fascia and tragal perichondrium had more anatomic proximity, compliance and translucency. The mode of action of these biological graft materials is that it provides support for the membrane remnant to proliferate and heal the defect. The temporalis fascia is thin, translucent and available in sufficient amount; but due to its close resemblance with tympanomeatal flap in color it may be displaced unintentionally during handling. However the reported success rate of temporalis fascia graft in literature varies from 93 to 97%.

On the other hand cartilage is middle ear friendly and survives for comparatively longer time due to the fact that its nourishment is based on diffusion process. Due to rigid nature of cartilage it prevents medialization of the graft to promontory in case of severe eustachian tube dysfunction. Cartilage graft is used in cases of chronically malfunction eustachian tube, adhesive otitis media, recurrent perforation and large TM perforation. But its demerits are its thick nature which hinders sound conduction and it is limited availability. The success rate of the cartilage graft tympanoplasty varies in the literature from 43 - 100%.

Chronic suppurative otitis media is an endemic health problem in our society. The reasons could be probably low literacy level, communities situated far flung from health facilities, lack of specialist service to the public in outreach area and inappropriate treatment of the middle ear infections. Sufficient number of patient suffering from inactive mucosal chronic otitis media with decreased hearing are presenting to otolaryngology unit. Tympanoplasty is the surgery of choice for chronic otitis media inactive mucosal type.

Hypothesis is that cartilage graft tympanoplasty is more successful than temporalis fascia tympanoplasty.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyberpakhtunkhwa
    • Peshawar, Khyberpakhtunkhwa, Pakistan, 25000
      • Fazali Wahid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tympanoplasty with tragal cartilage; Tympanoplasty was performed using tragal cartilage graft	Procedure: Tympanoplasty using tragal cartilage graft; tympanoplasty type I is performed using tragal cartilage in arm 1
Active Comparator: tympanoplasty with temporalis fascia; Tympanoplasty was performed using temporalis fascia graft	Procedure: Tympanoplasty using temporalis fascia graft; tympanoplasty type I is performed using temporalis fascia in arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft take up	the graft take rate is determined in both the groups	06 months of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective change in hearing level	Change in hearing level is objectively assessed by performing pure tone audiometry and that is recorded in decibels on audiogram	03 months of follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing satisfaction: whispering test	Individual hearing satisfaction will be assessed subjectively, by whispering test in which whispering sound is offered to the individual and improvement in hearing level is recorded on proforma	05 months of follow up

Collaborators and Investigators

• Sponsor: Lady Reading Hospital, Pakistan
• Investigators: Study Director: Zahid Nazar, Lady Reading Hospital, Peshawar, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Cartilage; Hearing loss; Tympanoplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive
• Other Study ID Numbers: LadyRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: This data can be share with other researcher through indexed journal
• IPD Sharing Time Frame: UPTO 5 YEARS
• IPD Sharing Access Criteria: in 6 months and for 5 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code