Clinical Trial

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

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07462676
Lead Sponsor Anhui Provincial Hospital
Collaborators: The First Affiliated Hospital of Bengbu Medical University, Wannan Medical College Yijishan Hospital, Fuyang people's hospital
Conditions Ventriculoperitoneal Shunt (VPS), Cranioplasty
Enrollment 300 participants
Start Date 2026-04-01
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-10