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NCT07462676

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

Not yet recruiting NA Last updated 10 March 2026
What this trial tests

NA trial testing Time of choosing VPS and VP in Ventriculoperitoneal Shunt (VPS) in 300 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
31 August 2026
30 November 2026

Quick facts

Lead sponsorAnhui Provincial Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment300
Start date1 April 2026
Primary completion31 August 2026
Estimated completion30 November 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Anhui Provincial Hospital

Who can join

Adults 18 to 70, any sex, with Ventriculoperitoneal Shunt (VPS) or Cranioplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Anhui Provincial Hospital trials

Trials by the same sponsor.

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Data sources for this page

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