Ventriculoperitoneal Shunt (VPS)NCT07462676
Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.
A study testing Time of choosing VPS and VP in people with Ventriculoperitoneal Shunt (VPS) and Cranioplasty, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventriculoperitoneal Shunt (VPS), Cranioplasty
- What is being tested?
- Time of choosing VPS and VP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients who have undergone decompressive craniectomy (DC) for conditions such as Traumatic Brain Injury (TBI), Intracerebral Hemorrhage (ICH), Subarachnoid Hemorrhage (SAH), or Ischemic Stroke (IS), and present with a skull defect concurrent with hydrocephalus. Hydrocephalus must be confirmed by cranial CT/MRI and cerebrospinal fluid pressure measurement.
- 2.A definitive diagnosis of hydrocephalus must meet the following criterion: presence of ventriculomegaly (Evans Index > 0.3), accompanied by either elevated intracranial pressure (or high bone flap pressure) OR clinical symptoms such as headache, vomiting, or impaired consciousness.
- 3.Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery.
- 4.Informed consent: The patient or their legal guardian must provide written informed consent.
Who cannot join
- Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases).
- Patients requiring bilateral cranioplasty.
- Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty.
- Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery.
- Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase.
- Patients with a known allergy or hypersensitivity to the surgical materials used (e.g., PEEK implants, shunt components).
- Pregnant or lactating women.
- Patients unable or unwilling to comply with the required follow-up schedule. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230036
Hao Xu, MD Ph.D, 18019576586, Xuhao2021@ustc.edu.cn
About this study
Official title: A Multicenter, Randomized Trial Comparing Simultaneous and Staged Surgical Management for Ventriculoperitoneal Shunt and Cranioplasty.
The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus. The main observation will be the occurrence of complications such as postoperative infection, reoperation, shunt tube obstruction, hematoma, and subdural effusion. This will provide high-quality evidence for clinical selection of appropriate strategies.The concurrent surgery group needs to complete the VPS and CP in the same operation, and the sequence of the surgeries is determined based on the patient's condition and is recorded.However, the staged surgery group requires two surgeries, with an interval of 2 to 8 weeks and the operation order is determined by randomization.Within 1 week after surgery, participants should cooperate to monitor vital signs, assess neurological function ( such as GCS、GOS, etc.), conduct head CT examinations regularly to observe the postoperative intracranial condition, and record the occurrence of postoperative complications.Postoperative follow-up should last for at least 6 months.Outpatient or telephone follow-ups should be conducted at 1 week, 1 month, 3 months, and 6 months after the surgery.During each follow-up, a neurological function assessment and quality of life score (such as the SF-36 Health Survey) should be completed, and the occurrence of postoperative complications should be recorded.
Read the detailed description
Study Design and Setting This study is a prospective, multi-center randomized controlled trail and partly conducted in the First Affiliated Hospital of USTC in China.Patients especially who have following conditions:(1、having a history of prior CP or VPS. surgical.2、requiring bilateral CP.3、unsuitable for simulataneous surgery) will be recruited to the study.Before the operation, patients and their family member will be fully informed of the surgical risks.
Evaluation Endpoints Efficacy Endpoints:1. Neurological functional recovery: Assessed using the modified Rankin Scale (mRS) and Glasgow Coma Scale (GCS). Improvement is defined as a reduction in mRS score of ≥1 point or an increase in GCS score of ≥2 points at 12 months postoperatively.
- Change in ventricular size: Postoperative cranial CT at 6 months showing a ≥20% reduction in the width of the lateral ventricular body compared to preoperative measurements.
Safety Endpoints1. Subdural effusion: Incidence of subdural fluid collection >1 cm in thickness with mass effect, as shown on CT scan at 1 month postoperatively.
- Infection: Incidence of overall infection, central nervous system infection, cranioplasty site infection, and shunt infection.
- Shunt obstruction: Incidence of shunt obstruction requiring surgical revision within 6 months postoperatively.
- Hematoma: Incidence of epidural/subdural hematoma or intracranial hematoma requiring intervention.
- Reoperation rate: Proportion of patients requiring secondary surgery due to complications within 1 year postoperatively.
- Conditions
- Ventriculoperitoneal Shunt (VPS), Cranioplasty
- Being tested
- Time of choosing VPS and VP
- Keywords
- Ventriculoperitoneal Shunt, cranioplasty, Postoperative Complications, Hydrocephalus
- Medical subject headings
- Postoperative Complications, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time of choosing VPS and VPProcedure or surgery
Randomization of patients with the time of choosing VPS and VP
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Surgery Group | Active comparator | Participants in this arm will undergo both the ventriculoperitoneal shunt (VPS) and cranioplasty (CP) procedures in a single operative session. The two procedures are performed sequentially under one anesthesia. Receives: Procedure: Time of choosing VPS and VP |
| Staged Surgery Group | Sham comparator | Participants in this arm will undergo the ventriculoperitoneal shunt (VPS) and cranioplasty (CP) procedures in two separate operations. The two procedures are spaced 4 to 8 weeks apart. The order of procedures (VPS first or CP first) may be determined by the clinical team based on the patient's condition. Receives: Procedure: Time of choosing VPS and VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Complication Rate
A composite outcome measuring the occurrence of any of the following postoperative complications within 1 year:
- Infections (overall, central nervous system, cranioplasty site, shunt-related)
- Reoperation due to complications (e.g., infection, shunt obstruction)
- Shunt obstruction requiring intervention
- Hematoma (epidural, subdural, intracranial) requiring intervention
- Subdural effusion with clinical symptoms Unit of Measure: Proportion of participants with at least one complication(%)
Measured: within 1year postoperatively
Secondary outcomes (7)
Functional Independence measured by modified Rankin Scale (mRS)
Assessment of global disability and functional outcome using the modified Rankin Scale. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death). Higher scores indicate worse outcomes (greater disability).
Measured: within 12 months postoperatively
Level of Consciousness measured by Glasgow Coma Scale (GCS)
Assessment of neurological status and consciousness level using the Glasgow Coma Scale. The GCS is a 15-point scale (range 3-15) evaluating eye, verbal, and motor responses. Higher scores indicate better neurological function.
Measured: within 12 months postoperatively
Quality of Life measured by 36-Item Short Form Survey (SF-36)
Assessment of health-related quality of life using the 36-Item Short Form Survey (SF-36). The SF-36 is a 36-item questionnaire that yields eight scaled scores, each ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Scale Info: Each of the eight domains is scored from 0 to 100, with higher scores representing a better quality of life.
Measured: 6 months postoperatively
Total Operative Time
Duration of the surgical procedure from incision to closure. Unit of Measures:minutes
Measured: intraoperative
Intraoperative Blood Loss
Estimated volume of blood lost during the surgical procedure. Unit of Measure: milliliters (ML)
Measured: intraoperative
Total Medical Costs
Total direct medical costs incurred during the hospitalization for the surgery (including costs for both surgeries in the staged group).
Unit of Measure: cost in local currency (e.g., CNY)
Measured: during the postoperative hospitalization period, up to 30 days
Total Length of Hospital Stay
Total number of days from admission to discharge after the index surgery (or after the second surgery in the staged group).
Unit of Measure: days
Measured: during the postoperative hospitalization period, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventriculoperitoneal Shunt (VPS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University, Wannan Medical College Yijishan Hospital, Fuyang people's hospital
- Responsible party
- Sponsor
- Investigators
- Hao Xu, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462676
- Sponsor's protocol ID
- 2025KY492
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial Comparing Simultaneous and Staged Surgical Management for Ventriculoperitoneal Shunt and Cranioplasty.
- ClinicalTrials.gov ID
- NCT07462676
- Acronym / sponsor ID
- 2025KY492
- Conditions
- Ventriculoperitoneal Shunt (VPS), Cranioplasty
- Keywords
- Ventriculoperitoneal Shunt, cranioplasty, Postoperative Complications, Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University, Wannan Medical College Yijishan Hospital, Fuyang people's hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus. The main observation will be the occurrence of complications such as postoperative infection, reoperation, shunt tube obstruction, hematoma, and subdural effusion. This will provide high-quality evidence for clinical selection of appropriate strategies.The concurrent surgery group needs to complete the VPS and CP in the same operation, and the sequence of the surgeries is determined based on the patient's condition and is recorded.However, the staged surgery group requires two surgeries, with an interval of 2 to 8 weeks and the operation order is determined by randomization.Within 1 week after surgery, participants should cooperate to monitor vital signs, assess neurological function ( such as GCS、GOS, etc.), conduct head CT examinations regularly to observe the postoperative intracranial condition, and record the occurrence of postoperative complications.Postoperative follow-up should last for at least 6 months.Outpatient or telephone follow-ups should be conducted at 1 week, 1 month, 3 months, and 6 months after the surgery.During each follow-up, a neurological function assessment and quality of life score (such as the SF-36 Health Survey) should be completed, and the occurrence of postoperative complications should be recorded.
Detailed description
Study Design and Setting This study is a prospective, multi-center randomized controlled trail and partly conducted in the First Affiliated Hospital of USTC in China.Patients especially who have following conditions:(1、having a history of prior CP or VPS. surgical.2、requiring bilateral CP.3、unsuitable for simulataneous surgery) will be recruited to the study.Before the operation, patients and their family member will be fully informed of the surgical risks.
Evaluation Endpoints Efficacy Endpoints:1. Neurological functional recovery: Assessed using the modified Rankin Scale (mRS) and Glasgow Coma Scale (GCS). Improvement is defined as a reduction in mRS score of ≥1 point or an increase in GCS score of ≥2 points at 12 months postoperatively.
- Change in ventricular size: Postoperative cranial CT at 6 months showing a ≥20% reduction in the width of the lateral ventricular body compared to preoperative measurements.
Safety Endpoints1. Subdural effusion: Incidence of subdural fluid collection >1 cm in thickness with mass effect, as shown on CT scan at 1 month postoperatively.
- Infection: Incidence of overall infection, central nervous system infection, cranioplasty site infection, and shunt infection.
- Shunt obstruction: Incidence of shunt obstruction requiring surgical revision within 6 months postoperatively.
- Hematoma: Incidence of epidural/subdural hematoma or intracranial hematoma requiring intervention.
- Reoperation rate: Proportion of patients requiring secondary surgery due to complications within 1 year postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Surgery Group | Active comparator | Procedure: Time of choosing VPS and VPParticipants in this arm will undergo both the ventriculoperitoneal shunt (VPS) and cranioplasty (CP) procedures in a single operative session. The two procedures are performed sequentially under one anesthesia. |
| Staged Surgery Group | Sham comparator | Procedure: Time of choosing VPS and VPParticipants in this arm will undergo the ventriculoperitoneal shunt (VPS) and cranioplasty (CP) procedures in two separate operations. The two procedures are spaced 4 to 8 weeks apart. The order of procedures (VPS first or CP first) may be determined by the clinical team based on the patient's condition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Patients who have undergone decompressive craniectomy (DC) for conditions such as Traumatic Brain Injury (TBI), Intracerebral Hemorrhage (ICH), Subarachnoid Hemorrhage (SAH), or Ischemic Stroke (IS), and present with a skull defect concurrent with hydrocephalus. Hydrocephalus must be confirmed by cranial CT/MRI and cerebrospinal fluid pressure measurement.
- 2.A definitive diagnosis of hydrocephalus must meet the following criterion: presence of ventriculomegaly (Evans Index > 0.3), accompanied by either elevated intracranial pressure (or high bone flap pressure) OR clinical symptoms such as headache, vomiting, or impaired consciousness.
- 3.Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery.
- 4.Informed consent: The patient or their legal guardian must provide written informed consent.
Key exclusion criteria (8 listed)
- Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases).
- Patients requiring bilateral cranioplasty.
- Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty.
- Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery.
- Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time of choosing VPS and VPRandomization of patients with the time of choosing VPS and VP | Procedure or surgery | Simultaneous Surgery Group, Staged Surgery Group |
Primary outcome
Overall Complication Rate
Time frame: within 1year postoperatively
A composite outcome measuring the occurrence of any of the following postoperative complications within 1 year: 1. Infections (overall, central nervous system, cranioplasty site, shunt-related) 2. Reoperation due to complications (e.g., infection, shunt obstruction) 3. Shunt obstruction requiring intervention 4. Hematoma (epidural, subdural, intracranial) requiring intervention 5. Subdural effusion with clinical symptoms Unit of Measure: Proportion of participants with at least one complication(%)
7 secondary outcomes
Functional Independence measured by modified Rankin Scale (mRS)
Time frame: within 12 months postoperatively
Level of Consciousness measured by Glasgow Coma Scale (GCS)
Time frame: within 12 months postoperatively
Quality of Life measured by 36-Item Short Form Survey (SF-36)
Time frame: 6 months postoperatively
Total Operative Time
Time frame: intraoperative
Intraoperative Blood Loss
Time frame: intraoperative
Total Medical Costs
Time frame: during the postoperative hospitalization period, up to 30 days
Total Length of Hospital Stay
Time frame: during the postoperative hospitalization period, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Related trials for Ventriculoperitoneal Shunt (VPS)
Recruiting
Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
Idiopathic Normal Pressure Hydrocephalus (INPH)
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.
Hao Xu study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time of choosing VPS and VP in people with Ventriculoperitoneal Shunt (VPS) and Cranioplasty, run by Anhui Provincial Hospital 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Xu, MD Ph.D (18019576586, Xuhao2021@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Complication Rate (time frame: within 1year postoperatively). 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 10 Mar 2026.