NCT07462676

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

A Multicenter, Randomized Trial Comparing Simultaneous and Staged Surgical Management for Ventriculoperitoneal Shunt and Cranioplasty.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Design and Setting This study is a prospective, multi-center randomized controlled trail and partly conducted in the First Affiliated Hospital of USTC in China.Patients especially who have following conditions:(1、having a history of prior CP or VPS. surgical.2、requiring bilateral CP.3、unsuitable for simulataneous surgery) will be recruited to the study.Before the operation, patients and their family member will be fully informed of the surgical risks. Evaluation Endpoints Efficacy Endpoints:1. Neurological functional recovery: Assessed using the modified Rankin Scale (mRS) and Glasgow Coma Scale (GCS). Improvement is defined as a reduction in mRS score of ≥1 point or an increase in GCS score of ≥2 points at 12 months postoperatively. 2\. Change in ventricular size: Postoperative cranial CT at 6 months showing a ≥20% reduction in the width of the lateral ventricular body compared to preoperative measurements. Safety Endpoints1. Subdural effusion: Incidence of subdural fluid collection \>1 cm in thickness with mass effect, as shown on CT scan at 1 month postoperatively. 2\. Infection: Incidence of overall infection, central nervous system infection, cranioplasty site infection, and shunt infection. 3\. Shunt obstruction: Incidence of shunt obstruction requiring surgical revision within 6 months postoperatively. 4\. Hematoma: Incidence of epidural/subdural hematoma or intracranial hematoma requiring intervention. 5\. Reoperation rate: Proportion of patients requiring secondary surgery due to complications within 1 year postoperatively.

Conditions

• Ventriculoperitoneal Shunt (VPS)
• Cranioplasty

Interventions

Type	Name	Description
PROCEDURE	Time of choosing VPS and VP	Randomization of patients with the time of choosing VPS and VP

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-08-31
• Completion: 2026-11-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: China