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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
Randomization of patients with the time of choosing VPS and VP
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Overall Complication Rate
A composite outcome measuring the occurrence of any of the following postoperative complications within 1 year: 1. Infections (overall, central nervous system, cranioplasty site, shunt-related) 2. Reoperation due to complications (e.g., infection, shunt obstruction) 3. Shunt obstruction requiring intervention 4. Hematoma (epidural, subdural, intracranial) requiring intervention 5. Subdural effusion with clinical symptoms Unit of Measure: Proportion of participants with at least one complication(%)
Time frame: within 1year postoperatively
Functional Independence measured by modified Rankin Scale (mRS)
Assessment of global disability and functional outcome using the modified Rankin Scale. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death). Higher scores indicate worse outcomes (greater disability).
Time frame: within 12 months postoperatively
Level of Consciousness measured by Glasgow Coma Scale (GCS)
Assessment of neurological status and consciousness level using the Glasgow Coma Scale. The GCS is a 15-point scale (range 3-15) evaluating eye, verbal, and motor responses. Higher scores indicate better neurological function.
Time frame: within 12 months postoperatively
Quality of Life measured by 36-Item Short Form Survey (SF-36)
Assessment of health-related quality of life using the 36-Item Short Form Survey (SF-36). The SF-36 is a 36-item questionnaire that yields eight scaled scores, each ranging from 0 to 100, with higher scores indicating better health-related quality of life. Scale Info: Each of the eight domains is scored from 0 to 100, with higher scores representing a better quality of life.
Time frame: 6 months postoperatively
Total Operative Time
Duration of the surgical procedure from incision to closure. Unit of Measures:minutes
Time frame: intraoperative
Intraoperative Blood Loss
Estimated volume of blood lost during the surgical procedure. Unit of Measure: milliliters (ML)
Time frame: intraoperative
Total Medical Costs
Total direct medical costs incurred during the hospitalization for the surgery (including costs for both surgeries in the staged group). Unit of Measure: cost in local currency (e.g., CNY)
Time frame: during the postoperative hospitalization period, up to 30 days
Total Length of Hospital Stay
Total number of days from admission to discharge after the index surgery (or after the second surgery in the staged group). Unit of Measure: days
Time frame: during the postoperative hospitalization period, up to 30 days
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