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

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

Study Overview

• Status: Recruiting
• Conditions: Hydrocephalus, Communicating
• Intervention / Treatment: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Junfeng Feng Chief Director, MD，PhD; Phone Number: 86-13512193229; Email: fengjfmail@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Junfeng Feng, MD, PhD; Phone Number: 86-21-68383707; Email: fengjfmail@163.com
      • Contact: Yanqing Ni, MD; Phone Number: 86-21-68383707; Email: pd120xz@126.com
      • Contact: Qing Mao, MD, PhD
      • Contact: Junfeng Feng, MD, PhD
      • Contact: Ru Gong, MD
      • Contact: Jiyuan Hui, MD
      • Contact: Ke Cao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients 18 years of age and older who require surgical treatment with lumboperitoneal shunt for communicating hydrocephalus

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Oberservation Group; Patient requiring surgical treatment with lumboperitoneal shunt for communicating hydrocephalus

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary outcome	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	preoperation to 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary outcome	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.	preoperation to 6 months after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: LY2024-070-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No