Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618053
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-10
Brief Title:
The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CESSO
Brief Summary:
Otosclerosis is a localized disorder of the otic capsule characterized by bone resorption anterior to the oval window in the region of the fissula ante fenestram This process leads to new sclerotic bone formation resulting in stapes footplate fixation It is one of the most common causes of progressive conductive hearing loss in young adults between the age of 30 and 50 year-old As the disease advances hearing loss can become mixed and even purely sensorineural due to the pathological process extending into the cochlea
Stapes surgery is the gold standard procedure for restoring mechanical sound transmission through the middle ear For patients who are not candidates for surgery hearing aids offer a valid alternative Over the years stapes surgery has evolved into a minimally invasive procedure that can be safely performed as day surgery under either local or general anesthesia
The COVID-19 crisis has exacerbated a shortage in anesthesiology teams limiting operating room availability To address this issue stapes surgery for otosclerosis under local anesthesia were increasingly performed Local anesthesia has several advantages it allows for immediate hearing tests after prosthesis placement enabling early detection and correction of vertigo caused by prosthesis displacement thus minimizing major complications Additionally local anesthesia reduces exposure to general anesthesia thereby decreasing postoperative morbidities
While there are few studies comparing outcomes and complications of stapes surgery based on the type of anesthesia a systematic review in 2013 found no difference in postoperative air-bone gap ABG sensorineural hearing loss SNHL or postoperative vertigo between procedures performed under local versus general anesthesia No studies have evaluated or compared the cost-effectiveness of stapes surgery for otosclerosis performed under local versus general anesthesia
This study hypotheses that patients undergoing stapes surgery under local anesthesia will have equivalent outcomes to those under general anesthesia with the potential for reduced costs and operative time
Stapes surgery is the gold standard procedure for restoring mechanical sound transmission through the middle ear For patients who are not candidates for surgery hearing aids offer a valid alternative Over the years stapes surgery has evolved into a minimally invasive procedure that can be safely performed as day surgery under either local or general anesthesia
The COVID-19 crisis has exacerbated a shortage in anesthesiology teams limiting operating room availability To address this issue stapes surgery for otosclerosis under local anesthesia were increasingly performed Local anesthesia has several advantages it allows for immediate hearing tests after prosthesis placement enabling early detection and correction of vertigo caused by prosthesis displacement thus minimizing major complications Additionally local anesthesia reduces exposure to general anesthesia thereby decreasing postoperative morbidities
While there are few studies comparing outcomes and complications of stapes surgery based on the type of anesthesia a systematic review in 2013 found no difference in postoperative air-bone gap ABG sensorineural hearing loss SNHL or postoperative vertigo between procedures performed under local versus general anesthesia No studies have evaluated or compared the cost-effectiveness of stapes surgery for otosclerosis performed under local versus general anesthesia
This study hypotheses that patients undergoing stapes surgery under local anesthesia will have equivalent outcomes to those under general anesthesia with the potential for reduced costs and operative time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None