NCT06620952

Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 6.8% 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 O'Ring, 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).

Conditions

• Posterior Fossa Surgery

Interventions

Type	Name	Description
PROCEDURE	O-ring technique	"O-ring technique." consists on a different arrangement of fibrin-glue on a polymethilmetacrylate cranioplasty, with the aim to create a gasket to prevent CSF leakage

Timeline

• Start date: 2024-07-16
• Primary completion: 2024-10-30
• Completion: 2024-12-31
• First posted: 2024-10-01
• Last updated: 2025-05-01

Locations

1 site across 1 country: Italy