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

Starting soon · Not applicable

Conditions studied: Ventriculoperitoneal Shunt (VPS), Cranioplasty

In brief

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.

Key facts

Study ID

NCT07462676

Run by

Anhui Provincial Hospital

People needed

300

Starts

2026-04-01

Expected to finish

2026-11-30

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery.
• Informed consent: The patient or their legal guardian must provide written informed consent.

You may not qualify if…

• 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. -

Where it is running

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China

Full record on ClinicalTrials.gov

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