Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cranioplasty; Ventriculoperitoneal Shunt (VPS)
• Intervention / Treatment: Procedure: Time of choosing VPS and VP

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.

2. 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.

2. Infection: Incidence of overall infection, central nervous system infection, cranioplasty site infection, and shunt infection.

3. Shunt obstruction: Incidence of shunt obstruction requiring surgical revision within 6 months postoperatively.

4. Hematoma: Incidence of epidural/subdural hematoma or intracranial hematoma requiring intervention.

5. Reoperation rate: Proportion of patients requiring secondary surgery due to complications within 1 year postoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Xu, MD Ph.D; Phone Number: 18019576586; Email: Xuhao2021@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230036
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Hao Xu, MD Ph.D; Phone Number: 18019576586; Email: Xuhao2021@ustc.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases).
2. Patients requiring bilateral cranioplasty.
3. Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty.
4. Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery.
5. Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase.
6. Patients with a known allergy or hypersensitivity to the surgical materials used (e.g., PEEK implants, shunt components).
7. Pregnant or lactating women.
8. Patients unable or unwilling to comply with the required follow-up schedule. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Simultaneous Surgery Group; 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.	Procedure: Time of choosing VPS and VP; Randomization of patients with the time of choosing VPS and VP
Sham Comparator: Staged Surgery Group; 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.	Procedure: Time of choosing VPS and VP; Randomization of patients with the time of choosing VPS and VP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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(%)	within 1year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	6 months postoperatively
Total Operative Time	Duration of the surgical procedure from incision to closure. Unit of Measures:minutes	intraoperative
Intraoperative Blood Loss	Estimated volume of blood lost during the surgical procedure. Unit of Measure: milliliters (ML)	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)	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	during the postoperative hospitalization period, up to 30 days

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Collaborators: Fuyang people's hospital; The First Affiliated Hospital of Bengbu Medical University; Wannan Medical College Yijishan Hospital
• Investigators: Study Chair: Hao Xu, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Complications; Hydrocephalus; Ventriculoperitoneal Shunt; cranioplasty
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Hydrocephalus
• Other Study ID Numbers: 2025KY492

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No