Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620952
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Effect of the O-ring Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery an Explorative Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of the O-ring Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery an Explorative Study
Status:
RECRUITING
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:
ORing
Brief Summary:
Posterior fossa surgery represents on of the most demanding procedure in neurosurgery Retrosygmoid RS key-hole retrosygmoid KR and cerebellar hemispheric CH are the most common approaches used to access in this area Despite they are not technically difficult to perform these approaches can be burdened by postoperative cerebrospinal fluid CSF leakage both at short and long-term follow-up with an high risk of meningitis Many techniques were employed to avoid this risk but it can still be estimated between 2 and 11 according to literature1-4 Spena et al reported a CSF leakage rate of 68 in a previous experience5 As a consequence newer efforts are necessaries to avoid this potentially lethal complication By this explorative study we want to retrospectively analyzed our experience with a newer technique of bone closure called ORing in patients subdued to posterior fossa surgery by RS KR and CH approaches focusing on postoperative CSF leakage primary objective wound complications and subcutaneous CSF collections secondary objectives
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