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

Completed

• Conditions: Posterior Fossa Surgery
• Interventions: Procedure: O-ring technique

• Registration Number: NCT06620952
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• age ≥18 years,
• availability of pre- and postoperative radiological and clinical data,
• a follow-up period of at least 3 months.

Exclusion Criteria

• Lacking of clinical, radiological and surgical data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients operated for a disease located in posterior fossa	O-ring technique	Patients operated for a disease located in posterior fossa for which a RS, KR or CH approach has to be performed. Patients between January 2018 and October 2023 will be considered for the study. Lacking of clinical, radiological and surgical data represe

Primary Outcome Measures

Name	Time	Method
to estimate incidence of postoperative CSF leakage	7 days	cumulative incidence of postoperative CSF leakage

Secondary Outcome Measures

Name	Time	Method
to estimate incidence CSF leakage at 1- and 3-months of follow-up.	1 and 3 months	cumulative incidence of CSF leakage at 1- and 3-months follow-up
to estimate the incidence of wound complications postoperatively and at 1- and 3-months	1 and 3 months	cumulative incidence of wound complications postoperatively and at 1- and 3-months follow-up
to estimate the incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up	1 and 3 months	cumulative incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up

Trial Locations

Locations (1)

SC Neurochirurgia, Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy