Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

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Hydrocephalus
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Brief Title

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

Official Title

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study

Brief Summary

      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the
      surgical intervention time as primary outcome. All patients entering the University Hospital
      of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the
      study groups at admission or the day before the operation.

Detailed Description

      Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in
      neurosurgical practice. The position of the proximal ventricular catheter is important since
      it influences possible malfunction of the VPS. For the improvement of accuracy in proximal
      VPS placement, navigation-based insertion techniques have been developed. VPS placement using
      stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS
      placement using stereotactic navigation has shown a high accuracy of catheter placement,
      while the main limitations are that for referencing, the head of the patient needs to be
      fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement
      using a burr hole probe was described as an alternate for image-guided VPS placement
      technique. For US-G VPS placement head fixation or preoperative registration is not needed.
      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the
      surgical intervention time as primary outcome.

Study Type

Interventional

Primary Outcome

surgical intervention time (minutes)

Secondary Outcome

 Operation time (minutes)

Condition

Ventriculoperitoneal Shunt (VPS)

Intervention

US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

Study Arms / Comparison Groups

 US -G VPS placement
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

130

Start Date

February 26, 2020

Completion Date

August 2022

Primary Completion Date

August 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Informed Consent as documented by signature

          -  Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )

        Exclusion Criteria:

          -  Revision surgery due to former VPS placement using the same side and location for VPS
             placement or when no complete shunt is revised (proximal and distal), resulting in a
             shorter operation time

          -  Ventriculoatrial or ventriculopleural Placement

          -  Women who are pregnant or breast feeding

          -  Intention to become pregnant during the course of the study

          -  Previous enrolment into the current study

          -  Enrolment of the investigator, his/her family members, employees, and other dependent
             persons

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Severina Leu, Dr. med., 0041 76 537 84 28, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations

NCT ID

NCT04450797

Organization ID

2019-02157; ch20Leu

Responsible Party

Sponsor

Study Sponsor

University Hospital, Basel, Switzerland

Study Sponsor

Severina Leu, Dr. med., Principal Investigator, Department of Neurosurgery, University Hospital of Basel

Verification Date

June 2020