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

NCT07462676 · tracked via the Priya Life Science China tracker

Sponsor

Anhui Provincial Hospital

Phase

Not applicable

Started

2026-04-01

Last updated

2026-03-10

Condition(s) studied

Ventriculoperitoneal Shunt (VPS)Cranioplasty

Investigational drug(s) / intervention(s)

Time of choosing VPS and VP

Time of choosing VPS and VP: Randomization of patients with the time of choosing VPS and VP

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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. -

Primary outcome measure(s)

Overall Complication Rate — 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(%)

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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