Posterior Fossa SurgeryO'RingNCT06620952
Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study
An observational study of Posterior Fossa Surgery, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Fossa Surgery
- What is being tested?
- O-ring technique
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jul 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 represented exclusion criteria.
Who may be able to join
- age ≥18 years,
- availability of pre- and postoperative radiological and clinical data,
- a follow-up period of at least 3 months.
Who cannot join
- Lacking of clinical, radiological and surgical data
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Neurochirurgia, Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
About this 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).
- Conditions
- Posterior Fossa Surgery
- Being tested
- O-ring technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-ring techniqueProcedure or surgery
"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
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for a disease located in posterior fossa | 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 Receives: Procedure: O-ring technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
to estimate incidence of postoperative CSF leakage
cumulative incidence of postoperative CSF leakage
Measured: 7 days
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start16 Jul 2024
- Primary completion30 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Fossa SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Guerrini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620952
- Sponsor's protocol ID
- O'Ring
- Acronym
- O'Ring
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study
- ClinicalTrials.gov ID
- NCT06620952
- Acronym / sponsor ID
- O'Ring / O'Ring
- Conditions
- Posterior Fossa Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated for a disease located in posterior fossa | – | Procedure: O-ring techniquePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 represented exclusion criteria.
Key inclusion criteria (3 listed)
- age ≥18 years,
- availability of pre- and postoperative radiological and clinical data,
- a follow-up period of at least 3 months.
Key exclusion criteria (1 listed)
- Lacking of clinical, radiological and surgical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Patients operated for a disease located in posterior fossa |
Primary outcome
to estimate incidence of postoperative CSF leakage
Time frame: 7 days
cumulative incidence of postoperative CSF leakage
3 secondary outcomes
to estimate incidence CSF leakage at 1- and 3-months of follow-up.
Time frame: 1 and 3 months
to estimate the incidence of wound complications postoperatively and at 1- and 3-months
Time frame: 1 and 3 months
to estimate the incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up
Time frame: 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Fossa Surgery, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to estimate incidence of postoperative CSF leakage (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.