Prevalence of Trephined Syndrome After Decompressive Craniectomy (TS)

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. Identifier: NCT03186157
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Leemann Beatrice, University Hospital, Geneva

Brief Summary:
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 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
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
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

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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.

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.

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 identifier (NCT number): NCT03186157

Contact: Lukas Sveikata, MD +41795533825
Contact: Beatrice Leemann, MD +41 79 55 33 848

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


Responsible Party: Leemann Beatrice, medical doctor, University Hospital, Geneva Identifier: NCT03186157     History of Changes
Other Study ID Numbers: CER 11-234 (NAC 11-086)
First Posted: June 14, 2017    Key Record Dates
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
decompressive craniectomy
neurosurgical complications

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