Cranioplasty Cognitive Outcome Study

Summary

This will be a multicenter prospective randomized study of adult patients with an acquired skull defect as a result of craniectomy and considered suitable for cranioplasty, i.e. reconstruction of the skull defect, at all seven Hong Kong Hospital Authority neurosurgical units. Patients that underwent their primary craniectomy operation at any of the Hospital Authority neurosurgery centers from the 1st March 2019 and considered suitable for cranioplasty will be included in this study. Those who underwent their primary craniectomy before 1st March 2019 or at an institution other than the aforementioned neurosurgical units will be excluded. Data from clinical records, operation notes, medication-dispensing records, laboratory records and radiological reports will be collected.

30 adult patients with craniectomy will be recruited and randomized into two groups: "early" cranioplasty, i.e. performed within 3 months of craniectomy, and "late", i.e. cranioplasty performed more than 3 months after the operation. The aim of the study is to determine whether early cranioplasty can improve on patient's cognitive performance compared to those who undergo the procedure after 3 months.

Conditions

• Cognitive Impairment
• Brain Herniation

Interventions

PROCEDURE

"Early" cranioplasty

Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Sponsors & Collaborators

• The Queen Elizabeth Hospital

  collaborator OTHER

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• Prince of Wales Hospital, Shatin, Hong Kong

  collaborator OTHER

• Princess Margaret Hospital, Canada

  collaborator OTHER

• Tuen Mun Hospital

  collaborator OTHER_GOV

• Pamela Youde Nethersole Eastern Hospital

  collaborator OTHER

• Kwong Wah Hospital

  lead OTHER

Principal Investigators

• Calvin Mak, MBBS FRCS · Neurosurgery, Queen Elizabeth Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2020-09-01

Completion

2021-03-01

Countries

• China

Study Locations