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

NCT07462676 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-10

No results posted yet for this study

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

Interventions

PROCEDURE

Time of choosing VPS and VP

Randomization of patients with the time of choosing VPS and VP

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Wannan Medical College Yijishan Hospital

    collaborator OTHER

  • Fuyang people's hospital

    collaborator OTHER

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Hao Xu · The First Affiliated Hospital of University of Science and Technology of China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-08-31
Completion
2026-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07462676 on ClinicalTrials.gov