A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Communicating Hydrocephalus Undergoing Lumboperitoneal Shunt Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines.
- Who it may be relevant to
- Registry conditions: Hydrocephalus, Communicating. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Traffic Hydrocephalus Undergoing Lumbopeitoneal Shunt Surgery
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- primary outcome [Time frame: preoperation to 6 months after surgery]
Secondary outcome measures (1)
- secondary outcome [Time frame: preoperation to 6 months after surgery]
Eligibility criteria
Inclusion criteria
- Age of 18 years or older;
- Confirmed diagnosis of communicating hydrocephalus;
- Signed informed consent for surgery and informed consent for research.
Exclusion criteria
- Pregnant women;
- Inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong Univer — Shanghai
Identifiers
NCT: NCT06642129 · LY2024-070-B