Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-12-07
Brief Title:
Microscopic Versus Endoscopic Tympanoplasty
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Tragal Cartilage Graft Tympanoplasty Microscopic Versus Endoscopic
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study The investigatirs will compare surgical and anatomical outcomes of endoscopic and microscopic tympanoplasty type 1myringoplasty using tragal perichondrum and cartilage and conduct a post-treatment survey regarding
1 Graft uptake hearing outcome postoperative pain and healing time
2 Assess the operation time
1 Graft uptake hearing outcome postoperative pain and healing time
2 Assess the operation time
Detailed Description:
Tympanic membrane perforation repair or tympanoplasty is a successful technique and has been validated in numerous studies since Wullstein and Zollner first proposed it in 1952 Previously the technique was performed with illumination and magnification under a microscope It typically requires an extensive postauricular incision to get through the narrow and curved external auditory canal especially in child complex perforations The exclusive transcanal endoscopic tympanoplasty technique emerged in the 1990s it provides more direct and wider surgical viewing angle and it largely reduces the necessity for a traumatic postauricular incision in difficult cases It has been gaining ground rapidly in recent years Although closure rates tympanoplasty surgery can reach 90 or more higher failure rates are seen in children larger perforations chronic Eustachian tube dysfunction and in bilateral cases Postoperative improvement in hearing is closely related to the postoperative change in the tympanogram Postoperative hearing results and tympanograms are mainly influenced by the mucosal condition of the Eustachian tube ET orifice Relatively greater improvement in hearing is observed in the long-term follow- up Different graft materials have been proposed over the years to improve surgical outcomes the search for an ideal graft is a subject of continued discussion as transcanal endoscopic approaches have been proposed for larger and more complex perforations once reserved for postauricular techniques The temporalis fascia TF has been the most preferred graft material for conventional microscopic tympanoplasty via postauricular or endaural approaches it has theadvantages of having a readily available and plentiful source and though its durability has been challenged in recent years it is still widely used However with the increasing popularity of transcanal endoscopic ear surgery TEES an increasing number of otologists have adopted this technique and switched to using the nearby tragal perichondriumcartilage graft when the surgical route is changed The tragus has a pivotal function in reconstruction in ear surgery and it is limited in source hence harvest on an ad hoc basis may lead to donor insufficiency at ensuing surgeries Moreover the tragus constitutes the anterior cartilaginous skeleton of the EAM and plays a role in sound transmission maintaining its integrity would benefit future hearing device applications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None