Cranioplasty Cognitive Outcome Study

NCT ID: NCT03791996

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-03-01

Brief 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.

Detailed Description

Decompressive craniectomy, a neurosurgical procedure where a portion of the skull calvarium is removed, is a life-saving procedure. The complication rate of cranioplasty, a neurosurgical procedure where the acquired skull defect is reconstructed, ranges from 11% to 26% and includes postoperative hemorrhage and infection. (4) The syndrome of the trephined is a recognized long-term complication in which certain groups of patients, experience debilitating neurocognitive deficits in addition to chronic headache, dizziness, fatigability and clinical depression. (2) It is believed that the lack of an overlying bone may cause undue significant atmospheric pressure on the underlying cortex, thereby reducing cerebral perfusion and cerebrospinal fluid flow. There are reports that cognitive improvement can be observed in up to 30% of patients after cranioplasty yet the underlying mechanism for this observation is unclear. (1) Some studies have demonstrated enhanced cerebral perfusion by non-invasive investigations, but there is a lack of large scale systematically performed studies to verify such cerebral hemodynamic effects. (1-3) Clinical equipoise exists regarding the optimum timing of cranioplasty procedures after craniectomies. While the anecdotal practice of delaying cranioplasty for at least 3 months after a craniectomy is common, local and overseas observational studies suggest that performing early cranioplasties (i.e. within 3 months) is equally safe in terms of infection and other operative complications. (4-6)

Conditions

Cognitive Impairment; Brain Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Late" cranioplasty

Subjects undergoing cranioplasty within 3 months after craniectomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

"Early" cranioplasty

Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Group Type: EXPERIMENTAL

"Early" cranioplasty

Intervention Type: PROCEDURE

Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Interventions

"Early" cranioplasty

Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age greater than or equal to 18 years-old,

2. Craniectomy was performed due to head injury, infarct or spontaneous intracerebral hemorrhage, and benign tumors.

3. Craniectomy skull defect size of >10cm at its longest diameter

4. Craniectomy performed at any of the Hospital Authority's Neurosurgical Centers after 1st March 2019

Exclusion Criteria

1. Age older than 80 years-old,

2. Patients cannot communicate by obeying simple command,

3. Patients who are unfit for cranioplasty as decided by the treating neurosurgeon

4. Posterior fossa craniectomy

5. Craniectomy performed before 1st March 2019

6. Craniectomy performed at an institution outside the Hospital Authority

7. Any pre-existing illness that renders the patient moderately or severely disabled before the brain insult.

8. Patients that need an additional procedure e.g. cerebrospinal fluid shunting with cranioplasty in the same setting.

9. History of central nervous system infection

10. Craniectomy-related complications such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect patient's long-term cognitive outcome

11. Claustrophobia or any other medical condition that prohibits the patient from undergo MRI scanning

12. Patients who cannot understand spoken English or Chinese

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Queen Elizabeth Hospital

OTHER

Sponsor Role: collaborator

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role: collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Tuen Mun Hospital

OTHER_GOV

Sponsor Role: collaborator

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role: collaborator

Kwong Wah Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Woo Yat Ming

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Calvin Mak, MBBS FRCS

Role: PRINCIPAL_INVESTIGATOR

Neurosurgery, Queen Elizabeth Hospital

Locations

Kwong Wah Hospital

Hong Kong, Hong Kong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Calvin Mak, MBBS FRCS

Role: CONTACT

mhk349@ha.org.hk

35066026

Marina Lee

Role: CONTACT

leeymm@ha.org.hk

35066026

Facility Contacts

Peter YM Woo, FRCS (SN)

Role: primary

peterymwoo@gmail.com

852+ 3517 2275 ext. 2275

References

Halani SH, Chu JK, Malcolm JG, Rindler RS, Allen JW, Grossberg JA, Pradilla G, Ahmad FU. Effects of Cranioplasty on Cerebral Blood Flow Following Decompressive Craniectomy: A Systematic Review of the Literature. Neurosurgery. 2017 Aug 1;81(2):204-216. doi: 10.1093/neuros/nyx054.

Reference Type: BACKGROUND

PMID: 28368505 (View on PubMed)

Bender A, Heulin S, Rohrer S, Mehrkens JH, Heidecke V, Straube A, Pfefferkorn T. Early cranioplasty may improve outcome in neurological patients with decompressive craniectomy. Brain Inj. 2013;27(9):1073-9. doi: 10.3109/02699052.2013.794972. Epub 2013 May 10.

Reference Type: RESULT

PMID: 23662672 (View on PubMed)

Ashayeri K, M Jackson E, Huang J, Brem H, Gordon CR. Syndrome of the Trephined: A Systematic Review. Neurosurgery. 2016 Oct;79(4):525-34. doi: 10.1227/NEU.0000000000001366.

Reference Type: RESULT

PMID: 27489166 (View on PubMed)

Malcolm JG, Rindler RS, Chu JK, Grossberg JA, Pradilla G, Ahmad FU. Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. J Clin Neurosci. 2016 Nov;33:39-51. doi: 10.1016/j.jocn.2016.04.017. Epub 2016 Aug 4.

Reference Type: RESULT

PMID: 27499122 (View on PubMed)

Xu H, Niu C, Fu X, Ding W, Ling S, Jiang X, Ji Y. Early cranioplasty vs. late cranioplasty for the treatment of cranial defect: A systematic review. Clin Neurol Neurosurg. 2015 Sep;136:33-40. doi: 10.1016/j.clineuro.2015.05.031. Epub 2015 May 29.

Reference Type: RESULT

PMID: 26056810 (View on PubMed)

Tsang AC, Hui VK, Lui WM, Leung GK. Complications of post-craniectomy cranioplasty: risk factor analysis and implications for treatment planning. J Clin Neurosci. 2015 May;22(5):834-7. doi: 10.1016/j.jocn.2014.11.021. Epub 2015 Mar 28.

Reference Type: RESULT

PMID: 25827865 (View on PubMed)

Other Identifiers

CCO-RCT

Identifier Type: -

Identifier Source: org_study_id