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

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

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

Treatments tested in this trial

  • Time of choosing VPS and VP

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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