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

N/ACompletedNCT06620952

Fondazione IRCCS Policlinico San Matteo di Pavia35 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Posterior Fossa Surgery

Interventions

O-ring techniquePROCEDURE

"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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SC Neurochirurgia, Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Outcomes

Primary Outcomes

to estimate incidence of postoperative CSF leakage

cumulative incidence of postoperative CSF leakage

Time frame: 7 days

Secondary Outcomes

to estimate incidence CSF leakage at 1- and 3-months of follow-up.

cumulative incidence of CSF leakage at 1- and 3-months follow-up

Time frame: 1 and 3 months

to estimate the incidence of wound complications postoperatively and at 1- and 3-months

cumulative incidence of wound complications postoperatively and at 1- and 3-months follow-up

Time frame: 1 and 3 months

to estimate the incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up

cumulative incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up

Time frame: 1 and 3 months

Data from ClinicalTrials.gov

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