- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06383169
Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction
April 22, 2024 updated by: First Hospital of Zhangjiakou City
This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
86
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhangjiakou, China
- First Hospital of Zhangjiakou City
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This retrospective study analysed data from 86 patients who developed postoperative hydrocephalus following meningioma surgery, conducted between May 2019 and May 2022.
Based on the inclusion and exclusion criteria, patients were divided into two groups.
The control group (n = 43) received conventional treatment methods, and the observation group (n = 43) underwent external drainage of the lumbar cistern.
Description
Inclusion Criteria:
- diagnosis of meningiomas based on established diagnostic criteria and pathological confirmation
- postoperative development of hydrocephalus, specifically communicating hydrocephalus
- absence of other intracranial tumours or contraindications for surgery
Exclusion Criteria:
- concurrent mental disorders, coagulation dysfunction or organic diseases affecting other areas
- hematologic diseases, severe liver or kidney dysfunction
- patients discontinuing treatment or transferring to a higher-level hospital
- a history of hydrocephalus, such as obstructive hydrocephalus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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control group
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observation group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Comparison of general clinical data
Time Frame: 2 weeks
|
2 weeks
|
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Comparison of the response rate
Time Frame: 2 weeks
|
2 weeks
|
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Comparison of GCS scores and intracranial pressure
Time Frame: 2 weeks
|
2 weeks
|
|
Comparison of KPS scores and satisfaction
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 30, 2022
Study Registration Dates
First Submitted
April 22, 2024
First Submitted That Met QC Criteria
April 22, 2024
First Posted (Actual)
April 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- wanglizhong
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.