Insertion of Frontal Ventricular Catheter of VP Shunt in Congenital Hydrocephalus Guided by Trans Fontanelle Ultrasound

NCT ID: NCT06664372

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-12-01

Brief Summary

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The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt

Detailed Description

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Congenital Hydrocephalus is a very common congenital anomalie known as the abnormal accumulation of csf in the ventricles and subarachnoid spaces under high tension due to imbalance between synthesis and absorption of csf , The incidence of congenital hydrocephalus is higher in low income country than in high income countries Treatment options for hydrocephalus are multiple but the most common treatment option world wide is VP Shunt . Although, VP Shunt still has a high rate of failure as revisions are required in 30% - 40% of cases In Vp shunt insertion , the placement of ventricular catheter is done mainly by free hand technique but recently The trans fontanelle ultrasound guided placement of ventricular catheter become a standard technique in multiple centers The free hand technique has low accuracy rate in proper intraventricular placement of the proximal catheter than the ultrasound guided technique . On the other hand , the use of intra operative ultrasound can visualize the anatomy of lateral ventricles and choroid plexus which makes the placement of ventricular catheter more accurate than the blind free hand technique So we are aiming in this study to highlight the efficacy of ultrasound guided placement of ventricular catheter of the frontal shunt in decreasing the rate of proximal catheter obstruction and we choose the frontal shunt because it has an advantage over the occipital in rate of revisions as it has a lower rate

Conditions

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Ventriculoperitoneal Shunt Trans Fontanelle US Congenital Hydrocephalus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trans fontanelle US Guided VP Shunt

insertion of proximal vp shunt by trans fontanelle US

Group Type EXPERIMENTAL

Trans fontanelle US Guided VP Shunt

Intervention Type PROCEDURE

Insertion of proximal VP shunt catheter by trans fontanelle US

Interventions

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Trans fontanelle US Guided VP Shunt

Insertion of proximal VP shunt catheter by trans fontanelle US

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who are diagnosed with congenital Hydrocephalus
* age of patients : \< 2 years with patent Anterior Fontanelle
* Not operated with frontal shunt before

Exclusion Criteria

* patients who are diagnosed with congenital Hydrocephalus
* age of patients : \< 2 years with patent Anterior Fontanelle
* Not operated with frontal shunt before
Minimum Eligible Age

5 Days

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Salah Mohamed Omran

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed Elsayed Mohamed Elsayed, Prof

Role: CONTACT

+20 01016077797

Ali Ahmed Ali abdel aleem, Lecturer

Role: CONTACT

+20 01004242170

References

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Wang Z, Zhang Y, Hu F, Ding J, Wang X. Pathogenesis and pathophysiology of idiopathic normal pressure hydrocephalus. CNS Neurosci Ther. 2020 Dec;26(12):1230-1240. doi: 10.1111/cns.13526. Epub 2020 Nov 26.

Reference Type BACKGROUND
PMID: 33242372 (View on PubMed)

Sarikaya-Seiwert S, Schievelkamp AH, Born M, Wispel C, Haberl H, Shabo E. The impact of real-time ultrasound guidance on ventricular catheter placement in cerebrospinal fluid shunts - a single-center study. Ultraschall Med. 2025 Apr;46(2):170-176. doi: 10.1055/a-2352-9404. Epub 2024 Jun 25.

Reference Type BACKGROUND
PMID: 38917967 (View on PubMed)

Kullmann M, Khachatryan M, Schuhmann MU. Ultrasound-guided placement of ventricular catheters in first-time pediatric VP shunt surgery. Childs Nerv Syst. 2018 Mar;34(3):465-471. doi: 10.1007/s00381-017-3660-2. Epub 2017 Nov 22.

Reference Type BACKGROUND
PMID: 29167995 (View on PubMed)

Other Identifiers

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Transfontanelle US vp shunt

Identifier Type: -

Identifier Source: org_study_id

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