Prevalence of Trephined Syndrome After Decompressive Craniectomy (TS)
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|ClinicalTrials.gov Identifier: NCT03186157|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment|
|Trephined Syndrome Sinking Skin Flap Syndrome Traumatic Brain Injury Stroke Post Operative Hemorrhage Post-Op Complication Post-Op Infection||Procedure: Decompressive craniectomy Procedure: Cranioplasty|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
|Actual Study Start Date :||February 1, 2012|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2017|
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.
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.
- 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.
- 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.
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
|Contact: Lukas Sveikata, MDfirstname.lastname@example.org|
|Contact: Beatrice Leemann, MD||+41 79 55 33 848||Beatrice.Leemann@hcuge.ch|
|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|