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

ConditionsVentriculoperitoneal Shunt (VPS)Cranioplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAnhui Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Patients who have undergone decompressive craniectomy (DC) for conditions such as Traumatic Brain Injury (TBI), Intracerebral Hemorrhage (ICH), Subarachnoid Hemorrhage (SAH), or Ischemic Stroke (IS), and present with a skull defect concurrent with hydrocephalus. Hydrocephalus must be confirmed by cranial CT/MRI and cerebrospinal fluid pressure measurement.

Disqualifiers

Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases).

Patients requiring bilateral cranioplasty.

Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty.

Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time of choosing VPS and VP

    Procedure/Surgery

    Randomization of patients with the time of choosing VPS and VP

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Simultaneous Surgery GroupActive comparator 1 intervention
Group B: Staged Surgery GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Total Operative Time

Duration of the surgical procedure from incision to closure. Unit of Measures:minutes

Time frame
intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

The First Affiliated Hospital of Bengbu Medical University

Collaborator

Wannan Medical College Yijishan Hospital

Collaborator

Fuyang people's hospital

Collaborator

Source ClinicalTrials.gov

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