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Study on Mortality, Infections, and Surgeries in the Treatment of Hydrocephalus Caused by Infratentorial Tumors in Children and Adolescents

Observational, prospective, and multicenter study to assess Mortality, Infection Rates, and number of surgeries related to the treatment of Hydrocephalus Secondary to Infratentorial Tumors in childhood and adolescence

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-3kwr4tz
Enrollment
Unknown
Registered
2025-02-21
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Infratentorial Neoplasms

Interventions

This will be a concurrent, prospective, multicenter, controlled cohort study to assess the effect of various treatment modalities for hydrocephalus secondary to posterior fossa tumors (Endoscopic Thir
E04.035.188.850
E04.035.188.957
A08.186.211.140

Sponsors

Escola Paulista de Medicina
Lead Sponsor
Instituto de Oncologia Pediátrica - IOP/GRAACC
Collaborator

Eligibility

Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Patients of both sexes; under 18 years old; with a diagnosis of hydrocephalus secondary to a primary central nervous system tumor; located in the posterior fossa, characterized by clinical findings and radiological imaging (CT scan or MRI); Hydrocephalus secondary to a posterior fossa tumor will be characterized when the patient presents a tumor in the posterior fossa, causing obstruction of cerebrospinal fluid circulation; enlargement of the lateral ventricles and third ventricle, with this enlargement documented through imaging exams such as cranial CT or MRI; identification, in addition to the ventricular enlargement, of an increase in the temporal horns of the lateral ventricles (>2mm); and transependymal edema in the frontal and/or occipital horns of the lateral ventricles; Additionally, the patient must present signs and symptoms related to increased intracranial pressure, such as: headache; irritability; vomiting; strabismus and/or paresis of the 6th cranial nerve unilaterally or bilaterally; papilledema; bradycardia; hypertension; and altered level of consciousness (drowsiness, stupor, or coma); Participating centers will be those that offer, both through the public health system and/or the private healthcare system, surgical treatment for patients under 18 years old with posterior fossa tumors; Patients who have initially been treated for hydrocephalus at an external center may also be included, provided that all necessary information for study inclusion is available

Exclusion criteria

Exclusion criteria: Patients over 18 years old; patients with lesions in other sites that do not focus primarily on the posterior fossa; patients who have previously undergone surgical resection of posterior fossa tumors; patients without hydrocephalus associated with a posterior fossa tumor; patients with posterior fossa tumors and hydrocephalus but who will not undergo surgical resection of the lesion (for example, diffuse midline pontine gliomas); or cases considered only for biopsy of the lesion; patients who refuse to participate in the study; and patients whose data regarding hydrocephalus and its characterization cannot be retrieved with the necessary details for the study will be excluded from the study

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study will be the number of re-intervention surgeries for hydrocephalus treatment following the index surgery

Secondary

MeasureTime frame
The mortality rate will be assessed by recording the date of death and its relation to hydrocephalus or tumor progression;The infection rate will be evaluated by the number of patients presenting with surgical site infections or other complications

Countries

Brazil

Contacts

Public ContactMarcos Devanir da Costa

Escola Paulista de Medicina

marcos.devanir@unifesp.br+55-11-33854343 - Ramal: 2792

Outcome results

None listed

Source: REBEC (via WHO ICTRP)