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

NCT ID: NCT06642129

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hydrocephalus, Communicating

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Oberservation Group

Patient requiring surgical treatment with lumboperitoneal shunt for communicating hydrocephalus

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junfeng Feng

Chief Director of Brain Injury Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junfeng Feng Chief Director, MD,PhD

Role: CONTACT

86-13512193229

Facility Contacts

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Junfeng Feng, MD, PhD

Role: primary

86-21-68383707

Yanqing Ni, MD

Role: backup

86-21-68383707

Qing Mao, MD, PhD

Role: backup

Junfeng Feng, MD, PhD

Role: backup

Ru Gong, MD

Role: backup

Jiyuan Hui, MD

Role: backup

Ke Cao, MD

Role: backup

Other Identifiers

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LY2024-070-B

Identifier Type: -

Identifier Source: org_study_id

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