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

NCT07462676 | Not Yet Recruiting DMC

• 1 other identifier: 2025KY492
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventriculoperitoneal Shunt (VPS); Cranioplasty

Keywords

Ventriculoperitoneal Shunt; cranioplasty; Postoperative Complications; Hydrocephalus

Outcome Measures

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(%)

  within 1year postoperatively

Secondary Outcomes (7)

• Functional Independence measured by modified Rankin Scale (mRS)

  within 12 months postoperatively

• Level of Consciousness measured by Glasgow Coma Scale (GCS)

  within 12 months postoperatively

• Quality of Life measured by 36-Item Short Form Survey (SF-36)

  6 months postoperatively

• Total Operative Time

  intraoperative

• Intraoperative Blood Loss

  intraoperative

Study Arms (2)

Simultaneous Surgery Group

ACTIVE COMPARATOR

Participants in this arm will undergo both the ventriculoperitoneal shunt (VPS) and cranioplasty (CP) procedures in a single operative session. The two procedures are performed sequentially under one anesthesia.

Procedure: Time of choosing VPS and VP

Staged Surgery Group

SHAM COMPARATOR

Participants in this arm will undergo the ventriculoperitoneal shunt (VPS) and cranioplasty (CP) procedures in two separate operations. The two procedures are spaced 4 to 8 weeks apart. The order of procedures (VPS first or CP first) may be determined by the clinical team based on the patient's condition.

Procedure: Time of choosing VPS and VP

Interventions

Time of choosing VPS and VP PROCEDURE

Randomization of patients with the time of choosing VPS and VP

Simultaneous Surgery Group; Staged Surgery Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A definitive diagnosis of hydrocephalus must meet the following criterion: presence of ventriculomegaly (Evans Index \> 0.3), accompanied by either elevated intracranial pressure (or high bone flap pressure) OR clinical symptoms such as headache, vomiting, or impaired consciousness.
• Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery.
• Informed consent: The patient or their legal guardian must provide written informed consent.

You may not qualify if:

• 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.
• Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase.
• Patients with a known allergy or hypersensitivity to the surgical materials used (e.g., PEEK implants, shunt components).
• Pregnant or lactating women.
• Patients unable or unwilling to comply with the required follow-up schedule. -

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Wannan Medical College Yijishan Hospital: collaborator
• Fuyang people's hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230036, China

Location

MeSH Terms

Conditions

Postoperative Complications; Hydrocephalus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hao Xu

  The First Affiliated Hospital of University of Science and Technology of China

  STUDY CHAIR

Central Study Contacts

Hao Xu, MD Ph.D

CONTACT

18019576586; Xuhao2021@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Locations

CN (1)