Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT. (NCT07462676) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.
China300 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓.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.
Exclusion criteria
✕. 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.