Skip to main content
OpenTrials
Completed

NCT Number: NCT06620952

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Neurochirurgia, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

O-ring technique

Procedure

"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

Primary outcomes

  1. to estimate incidence of postoperative CSF leakage

    Time frame: 7 days

    cumulative incidence of postoperative CSF leakage

Secondary outcomes

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

    Time frame: 1 and 3 months

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

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

    Time frame: 1 and 3 months

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

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

    Time frame: 1 and 3 months

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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: O'Ring

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.