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Ventriculoperitoneal shunt insertion using a novel stereotactic frame: A Randomized Clinical Trial

Evaluation of a Novel 3D-Printed Stereotactic Frame for Ventriculoperitoneal Shunt Insertion: A Randomized Clinical Trial Integrating Surgical Accuracy and Airway Safety Under General Anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603889182652
Enrollment
108
Registered
2026-03-03
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Nervous System Diseases

Interventions

Conventional Freehand
Novel Stereotactic Frame

Sponsors

mansoura university
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age: Patients aged = 6 months (no upper age limit specified). Diagnosis: Diagnosis of hydrocephalus requiring ventriculoperitoneal (VP) shunt insertion, confirmed by neuroimaging (MRI or CT) demonstrating ventricular enlargement (e.g., Evans index > 0.3). Surgical Fitness: Patients deemed suitable for general anesthesia (GA) following standard preoperative evaluation, including anesthesia assessment.

Exclusion criteria

Exclusion criteria: Coagulopathy: Patients with bleeding disorders or coagulopathy (defined as INR > 1.5). Significant Midline Shift: Patients with intracranial pathology causing midline shift > 1 cm. Active Infection: Patients with evidence of active systemic or local infection (at surgical site). Prior Surgery: Patients with prior shunt surgery or any previous intracranial procedure that might distort anatomy. Severe Airway Compromise: Patients with severe airway compromise precluding safe administration of general anesthesia.

Design outcomes

Primary

MeasureTime frame
Proportion of optimal VP shunt catheter placement (tip in frontal horn of lateral ventricle, 1-2 cm anterior to foramen of Monro, no choroid plexus/foramen contact) on 24h postop CT, targeting =95% success (vs. 67-80% freehand).

Secondary

MeasureTime frame
Anesthesia airway protection: intubation time (2 laryngoscopy attempts, desaturation <90%), airway complications (e.g., aspiration, trauma).

Countries

Egypt

Contacts

Public Contactmohamed salama

lecturer of anesthesia and surgical icu faculty of medicine mansoura university

mohamed_615@mans.edu.eg00201069940993

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026