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Clinical Trials in China / NCT06642129
Recruiting Observational

A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Communicating Hydrocephalus Undergoing Lumboperitoneal Shunt Surgery

NCT06642129 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Observational
Started
2024-06-01
Last updated
2024-10-15

Condition(s) studied

Hydrocephalus, Communicating

Investigational drug(s) / intervention(s)

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines: Lumboperitoneal shunt (LPS) involves connecting the subarachnoid space of the lumbar spine to the peritoneal cavity through a pressure-adjustable unidirectional valve to shunt the appropriate amount of cerebrospinal fluid from the ventricles to the peritoneal cavity via the spinal canal, where it is absorbed through the peritoneum, to alleviate the increased intracranial pressure caused by the communicating hydrocephalus and the corresponding clinical symptoms.

Study summary

Target population: patients 18 years of age or older who require surgical treatment with lumboperitoneal shunt surgery for traffic hydrocephalus Estimated sample size: 30 cases. Study design: this study is a multicenter prospective observational study, with lumbar puncture pressure measurement before and during surgery, and shunt valve setting pressure set according to the requirements of clinical practice in the hospital where it is performed, and the collection of relevant data, including preoperative lumbar puncture pressure, intraoperative lumbar puncture pressure after anesthesia, shunt valve initial pressure, shunt valve pressure at 6 months pressure, length of the intravertebral shunt, and length of the intraperitoneal shunt. Complications, shunt effects, and the number of shunt valve adjustments during the 6-month period were also observed and recorded.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age of 18 years or older; 2. Confirmed diagnosis of communicating hydrocephalus; 3. Signed informed consent for surgery and informed consent for research. Exclusion Criteria: 1. Pregnant women; 2. Inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai Municipality Recruiting

More RenJi Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642129 on ClinicalTrials.gov ↗ ← All trials in China