Half-thickness Tragal Cartilage Graft vs Temporalis Fascia Graft Tympanoplasty Type I
Condition: Hearing Loss,Conductive
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive
Study type: Interventional

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.
    

Intervention name(s): Tympanoplasty using tragal cartilage graft; Tympanoplasty using temporalis fascia graft
Intervention type(s): Procedure; Procedure
Intervention description(s): tympanoplasty type I is performed using tragal cartilage in arm 1; tympanoplasty type I is performed using temporalis fascia in arm 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Cartilage; Hearing loss; Tympanoplasty