One surgery or two? new trial aims to settle debate on brain procedures
NCT ID NCT07462676
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares doing two brain surgeries—placing a shunt to drain fluid and repairing the skull—at the same time versus weeks apart. Researchers will track complications like infection, bleeding, and need for repeat surgery in 300 patients. The goal is to find out which approach is safer and leads to better recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgical procedure (ventriculoperitoneal shunt and cranioplasty)
- What this could lead to
- If successful, this could show that doing both surgeries at the same time is as safe or safer than doing them separately, potentially reducing hospital stays and recovery time.
- What could go wrong
- This is a relatively small, early-stage trial that hasn't started recruiting yet. The results may not apply to all patients, and both approaches carry risks like infection or need for repeat surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 2.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. 3.Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery. 4.Informed consent: The patient or their legal guardian must provide written informed consent. Exclusion Criteria: 1. Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases). 2. Patients requiring bilateral cranioplasty. 3. Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty. 4. Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery. 5. Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase. 6. Patients with a known allergy or hypersensitivity to the surgical materials used (e.g., PEEK implants, shunt components). 7. Pregnant or lactating women. 8. Patients unable or unwilling to comply with the required follow-up schedule. -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230036, China
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