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

Primary Purpose

Hearing Loss,Conductive

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Tympanoplasty using tragal cartilage graft
Tympanoplasty using temporalis fascia graft
Sponsored by
Lady Reading Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss,Conductive focused on measuring Cartilage, Hearing loss, Tympanoplasty

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fazali Wahid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

tympanoplasty with tragal cartilage

tympanoplasty with temporalis fascia

Arm Description

Tympanoplasty was performed using tragal cartilage graft

Tympanoplasty was performed using temporalis fascia graft

Outcomes

Primary Outcome Measures

Graft take up
the graft take rate is determined in both the groups

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2018
Last Updated
January 24, 2019
Sponsor
Lady Reading Hospital, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT03817242
Brief Title
Half-thickness Tragal Cartilage Graft vs Temporalis Fascia Graft Tympanoplasty Type I
Acronym
PTA
Official Title
Comparison of Half-thickness Tragal Cartilage Graft to Temporalis Fascia Graft
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Reading Hospital, Pakistan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss,Conductive
Keywords
Cartilage, Hearing loss, Tympanoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tympanoplasty I is performed in these patients in Group 1 tragal cartilage graft is used while in group 2 temporalis fascia graft is used
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tympanoplasty with tragal cartilage
Arm Type
Active Comparator
Arm Description
Tympanoplasty was performed using tragal cartilage graft
Arm Title
tympanoplasty with temporalis fascia
Arm Type
Active Comparator
Arm Description
Tympanoplasty was performed using temporalis fascia graft
Intervention Type
Procedure
Intervention Name(s)
Tympanoplasty using tragal cartilage graft
Intervention Description
tympanoplasty type I is performed using tragal cartilage in arm 1
Intervention Type
Procedure
Intervention Name(s)
Tympanoplasty using temporalis fascia graft
Intervention Description
tympanoplasty type I is performed using temporalis fascia in arm 2
Primary Outcome Measure Information:
Title
Graft take up
Description
the graft take rate is determined in both the groups
Time Frame
06 months of follow up
Secondary Outcome Measure Information:
Title
Objective change in hearing level
Description
Change in hearing level is objectively assessed by performing pure tone audiometry and that is recorded in decibels on audiogram
Time Frame
03 months of follow up
Other Pre-specified Outcome Measures:
Title
Hearing satisfaction: whispering test
Description
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
Time Frame
05 months of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahid Nazar
Organizational Affiliation
Lady Reading Hospital, Peshawar, Pakistan
Official's Role
Study Director
Facility Information:
Facility Name
Fazali Wahid
City
Peshawar
State/Province
Khyberpakhtunkhwa
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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