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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06620952
Acronym
O'Ring
Enrollment
35
Registered
2024-10-01
Start date
2024-07-16
Completion date
2024-12-31
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Fossa Surgery

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).

Interventions

PROCEDUREO-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

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
to estimate incidence of postoperative CSF leakage7 dayscumulative incidence of postoperative CSF leakage

Secondary

MeasureTime frameDescription
to estimate incidence CSF leakage at 1- and 3-months of follow-up.1 and 3 monthscumulative incidence of CSF leakage at 1- and 3-months follow-up
to estimate the incidence of wound complications postoperatively and at 1- and 3-months1 and 3 monthscumulative 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-up1 and 3 monthscumulative incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026