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Prevalence of Trephined Syndrome After Decompressive Craniectomy (TS)

This study is currently recruiting participants.
Verified June 2017 by Leemann Beatrice, University Hospital, Geneva
Sponsor:
ClinicalTrials.gov Identifier:
NCT03186157
First Posted: June 14, 2017
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Leemann Beatrice, University Hospital, Geneva
  Purpose
Decompressive craniectomy is frequently used to treat increased intracranial pressure or an intracranial mass effect. Trephined Syndrome describes a neurological deterioration, which is attributed to a large craniectomy. The symptomatology is varied but includes headache, aggravation of a hemisyndrome or cognitive disorders, often has an orthostatic component and improves or disappears with cranioplasty. The incidence of Trephined Syndrome has been reported between 7% and 26%. However, it might be underestimated if the course of cognitive functions before and after cranioplasty were insufficiently documented.

Condition Intervention
Trephined Syndrome Sinking Skin Flap Syndrome Traumatic Brain Injury Stroke Post Operative Hemorrhage Post-Op Complication Post-Op Infection Procedure: Decompressive craniectomy Procedure: Cranioplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on Risk Factors of Developing and Prevalence of Trephined Syndrome in Patients After Hemispheric Decompressive Craniectomy and Effect of Cranioplasty on Functional and Cognitive Recovery

Further study details as provided by Leemann Beatrice, University Hospital, Geneva:

Primary Outcome Measures:
  • Presence of Trephined Syndrome [ Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months). ]
    To determine the incidence and severity of the the Trephined Syndrome in relation to delay to cranioplasty.


Secondary Outcome Measures:
  • Complications related to cranioplasty [ Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months). ]
    To record the incidence of complications, such as hemorrhagic or infectious, related to cranioplasty intervention.

  • Relation of delay to cranioplasty with the risk of complications [ Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months). ]
    To investigate the relationship between cranioplasty delay and complications related with cranioplasty.


Estimated Enrollment: 60
Actual Study Start Date: February 1, 2012
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Decompressive craniectomy patients
All of the patients that undergo decompressive craniectomy due to intracranial mass lesion and are transferred to neuro-rehabilitation unit in our university hospital.
Procedure: Decompressive craniectomy
Decompressive craniectomy is a surgical procedure used to treat patients with acute intractable intracranial hypertension. It includes removing a large portion of lateral skull wall in order to alleviate the effects of increased intracranial pressure and allow the brain to expand.
Procedure: Cranioplasty
Cranioplasty is a routine neurosurgical procedure to repair the continuity of the bone tissue of the skull with autologous bone or synthetic bone flap from heterologous material.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing a decompressive craniectomy due to intracranial mass effect of non progressive origin and transferred to the neuro-rehabilitation unit of our hospital.
Criteria

Inclusion Criteria:

  • Patients with decompressive craniectomy for intracranial hypertension secondary to stroke, traumatic brain injury or other non-progressive cerebral pathology.

Exclusion Criteria:

  • patients suffering from a rapidly evolving cerebral pathology (e.g. tumor)
  • patients transferred to other hospitals before cranioplasty or whose follow-up can not be assured.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186157


Contacts
Contact: Lukas Sveikata, MD +41795533825 lukas.sveikata@hcuge.ch
Contact: Beatrice Leemann, MD +41 79 55 33 848 Beatrice.Leemann@hcuge.ch

Locations
Switzerland
Neuro-Rehabilitation Division, University Hospital of Geneva Recruiting
Genève, Switzerland, 1206
Contact: Béatrice Leemann, MD    +41 79 55 33 848    Beatrice.Leemann@hcuge.ch   
Contact: Armin Schnider, Prof    +41 22 37 23 701    Armin.Schnider@hcuge.ch   
Sub-Investigator: Lukas Sveikata, MD         
Sponsors and Collaborators
University Hospital, Geneva
  More Information

Publications:

Responsible Party: Leemann Beatrice, medical doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03186157     History of Changes
Other Study ID Numbers: CER 11-234 (NAC 11-086)
First Submitted: June 11, 2017
First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leemann Beatrice, University Hospital, Geneva:
trephined syndrome
sinking skin flap syndrome
craniectomy
decompressive craniectomy
neurosurgical complications

Additional relevant MeSH terms:
Syndrome
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Postoperative Complications
Blood Loss, Surgical
Postoperative Hemorrhage
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Intraoperative Complications