Supratentorial Brain Tumor Clinical Trial
NCT number | NCT01864499 |
Other study ID # | DINO-NEURO |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | May 14, 2013 |
Last updated | October 10, 2016 |
Neurosurgery for supratentorial brain tumor is frequently associated with preoperative
intracranial hypertension. The evaluation of intracranial pressure is available
noninvasively by measuring the diameter of the optic nerve sheath ultrasound.
The evaluation of intracranial pressure by measuring the DNO in perioperative is not
described in the literature. The investigators propose a pilot study to assess intracranial
pressure perioperative surgery for supratentorial brain tumor. The investigators consider a
diameter of the optic nerve sheath as normal and predictive of intracranial pressure below
20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the
normal healthy adult unanesthetized is 5 mm.
The main objective of the study is to compare the mean change in diameter of the optic nerve
between the postoperative and D2 between groups of patients undergoing resection of a brain
tumor and patients undergoing biopsy brain tumor.
Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients
is estimated according to the recruiting capabilities of neurosurgery for this type of
patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control
group: 20 patients Biopsy Brain Tumor.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Age = 18 years - Hospitalized for surgery of intracerebral tumors in the study group. - Hospitalized for a biopsy of intracerebral tumor lesion in the control group. Exclusion Criteria: - Age <18 years - Enucleation Prohibited to the achievement of an ocular ultrasound - Hypersensitivity to gel - Eye Wound - Massive facial fracture - Skin Infection Site |
N/A
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in mean changes that the sheath of postoperative optic nerve | Difference in mean changes that the sheath of postoperative optic nerve and J2 between groups of patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor | 2 days | |
Secondary | Difference in diameter of the sheath of the pre-and postoperative optic nerve | Difference in diameter of the sheath of the pre-and postoperative optic nerve and J2 and J5 for all patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor. | 5 days |
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