Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma SurgeryNCT06383169
Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction
An observational study of Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery, run by First Hospital of Zhangjiakou City at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observation group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of general clinical data
Measured: 2 weeks
Comparison of the response rate
Measured: 2 weeks
Comparison of GCS scores and intracranial pressure
Measured: 2 weeks
Comparison of KPS scores and satisfaction
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 May 2019
- Primary completion1 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of Zhangjiakou City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383169
- Sponsor's protocol ID
- wanglizhong
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT06383169
- Acronym / sponsor ID
- wanglizhong
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- First Hospital of Zhangjiakou CityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | – |
| control group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of general clinical data
Time frame: 2 weeks
Comparison of the response rate
Time frame: 2 weeks
Comparison of GCS scores and intracranial pressure
Time frame: 2 weeks
Comparison of KPS scores and satisfaction
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery, run by First Hospital of Zhangjiakou City at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of general clinical data (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.