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NCT07462676
Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.
NA trial testing Time of choosing VPS and VP in Ventriculoperitoneal Shunt (VPS) in 300 participants. Not yet recruiting.
31 August 2026
Quick facts
| Lead sponsor | Anhui Provincial Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 1 April 2026 |
| Primary completion | 31 August 2026 |
| Estimated completion | 30 November 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Time of choosing VPS and VP
Conditions studied
- Ventriculoperitoneal Shunt (VPS) — all drugs for Ventriculoperitoneal Shunt (VPS) →
- Cranioplasty — all drugs for Cranioplasty →
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.
Verify or expand the search:
- PubMed search for NCT07462676
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07462676 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Anhui Provincial Hospital
- Last refreshed: 10 March 2026
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