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NCT Number: NCT06642129

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

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.

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Key information

Conditions

Hydrocephalus, Communicating Brain Diseases Central Nervous System Diseases Hydrocephalus Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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 outcomes

  1. primary outcome

    Time frame: preoperation to 6 months after surgery

    • Measurement of preoperative bedside lumbar puncture pressure(cmH2O);
    • Measurement of lumbar puncture pressure after anesthesia during lumboperitoneal shunt surgery(cmH2O) ;
    • Initial setting of shunt valve;
    • Setting of shunt valve at 6 months after lumboperitoneal shunt surgery

Secondary outcomes

  1. secondary outcome

    Time frame: preoperation to 6 months after surgery

    The numbers of complications related to the lumboperitoneal shunt at 6 months after the shunt operation, including: subdural hemorrhage, ventricular hemorrhage, intracerebral hemorrhage, subdural effusion, shunt obstruction, resetting the shunt, intracranial infection, and epilepsy.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Acronym: LPP-LPS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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