NCT03186157

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

5.2 years

First QC Date

June 11, 2017

Last Update Submit

November 16, 2020

Conditions

Trephined SyndromeSinking Skin Flap SyndromeTraumatic Brain InjuryStrokePost Operative HemorrhagePost-Op ComplicationPost-Op Infection

Keywords

trephined syndromesinking skin flap syndromecraniectomydecompressive craniectomyneurosurgical complications

Outcome Measures

Primary Outcomes (1)

  • Presence of Trephined Syndrome

    To determine the incidence and severity of the the Trephined Syndrome in relation to delay to cranioplasty.

    From patients admission to discharge from rehabilitation (approx. 3 months).

Secondary Outcomes (3)

  • Complications related to cranioplasty

    From patients admission to discharge from rehabilitation (approx. 3 months).

  • Relation of delay to cranioplasty with neurological outcome

    From patients admission to discharge from rehabilitation (approx. 3 months).

  • Relation of delay to cranioplasty with complications post-cranioplasty

    From patients admission to discharge from rehabilitation (approx. 3 months).

Study Arms (1)

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 craniectomyProcedure: Cranioplasty

Interventions

Decompressive craniectomyPROCEDURE

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.

Decompressive craniectomy patients
CranioplastyPROCEDURE

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.

Decompressive craniectomy patients

Eligibility Criteria

Age14 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuro-Rehabilitation Division, University Hospital of Geneva

Geneva, 1206, Switzerland

Location

Related Publications (18)

  • Akins PT, Guppy KH. Sinking skin flaps, paradoxical herniation, and external brain tamponade: a review of decompressive craniectomy management. Neurocrit Care. 2008;9(2):269-76. doi: 10.1007/s12028-007-9033-z.

    PMID: 18064408BACKGROUND

  • Beauchamp KM, Kashuk J, Moore EE, Bolles G, Rabb C, Seinfeld J, Szentirmai O, Sauaia A. Cranioplasty after postinjury decompressive craniectomy: is timing of the essence? J Trauma. 2010 Aug;69(2):270-4. doi: 10.1097/TA.0b013e3181e491c2.

    PMID: 20699735BACKGROUND

  • Bijlenga P, Zumofen D, Yilmaz H, Creisson E, de Tribolet N. Orthostatic mesodiencephalic dysfunction after decompressive craniectomy. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):430-3. doi: 10.1136/jnnp.2006.099242. Epub 2006 Nov 21.

    PMID: 17119005BACKGROUND

  • Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133.

    PMID: 19612971BACKGROUND

  • Dujovny M, Agner C, Aviles A. Syndrome of the trephined: theory and facts. Crit Rev Neurosurg. 1999 Sep 24;9(5):271-278. doi: 10.1007/s003290050143.

    PMID: 10525845BACKGROUND

  • Fodstad H, Love JA, Ekstedt J, Friden H, Liliequist B. Effect of cranioplasty on cerebrospinal fluid hydrodynamics in patients with the syndrome of the trephined. Acta Neurochir (Wien). 1984;70(1-2):21-30. doi: 10.1007/BF01406039.

    PMID: 6741628BACKGROUND

  • Honeybul S. Complications of decompressive craniectomy for head injury. J Clin Neurosci. 2010 Apr;17(4):430-5. doi: 10.1016/j.jocn.2009.09.007. Epub 2010 Feb 23.

    PMID: 20181482BACKGROUND

  • Joseph V, Reilly P. Syndrome of the trephined. J Neurosurg. 2009 Oct;111(4):650-2. doi: 10.3171/2009.3.JNS0984.

    PMID: 19361266BACKGROUND

  • Kemmling A, Duning T, Lemcke L, Niederstadt T, Minnerup J, Wersching H, Marziniak M. Case report of MR perfusion imaging in sinking skin flap syndrome: growing evidence for hemodynamic impairment. BMC Neurol. 2010 Sep 11;10:80. doi: 10.1186/1471-2377-10-80.

    PMID: 20831824BACKGROUND

  • Mokri B. Orthostatic headaches in the syndrome of the trephined: resolution following cranioplasty. Headache. 2010 Jul;50(7):1206-11. doi: 10.1111/j.1526-4610.2010.01715.x. Epub 2010 Jun 18.

    PMID: 20561067BACKGROUND

  • Ng D, Dan NG. Cranioplasty and the syndrome of the trephined. J Clin Neurosci. 1997 Jul;4(3):346-8. doi: 10.1016/s0967-5868(97)90103-x.

    PMID: 18638981BACKGROUND

  • Sarov M, Guichard JP, Chibarro S, Guettard E, Godin O, Yelnik A, George B, Bousser MG, Vahedi K; DECIMAL investigators. Sinking skin flap syndrome and paradoxical herniation after hemicraniectomy for malignant hemispheric infarction. Stroke. 2010 Mar;41(3):560-2. doi: 10.1161/STROKEAHA.109.568543. Epub 2010 Jan 7.

    PMID: 20056926BACKGROUND

  • Schiffer J, Gur R, Nisim U, Pollak L. Symptomatic patients after craniectomy. Surg Neurol. 1997 Mar;47(3):231-7. doi: 10.1016/s0090-3019(96)00376-x.

    PMID: 9068692BACKGROUND

  • Stiver SI. Complications of decompressive craniectomy for traumatic brain injury. Neurosurg Focus. 2009 Jun;26(6):E7. doi: 10.3171/2009.4.FOCUS0965.

    PMID: 19485720BACKGROUND

  • Stiver SI, Wintermark M, Manley GT. Reversible monoparesis following decompressive hemicraniectomy for traumatic brain injury. J Neurosurg. 2008 Aug;109(2):245-54. doi: 10.3171/JNS/2008/109/8/0245.

    PMID: 18671636BACKGROUND

  • Thavarajah D, De Lacy P, Hussien A, Sugar A. The minimum time for cranioplasty insertion from craniectomy is six months to reduce risk of infection--a case series of 82 patients. Br J Neurosurg. 2012 Feb;26(1):78-80. doi: 10.3109/02688697.2011.603850. Epub 2011 Oct 5.

    PMID: 21973063BACKGROUND

  • Yadla S, Campbell PG, Chitale R, Maltenfort MG, Jabbour P, Sharan AD. Effect of early surgery, material, and method of flap preservation on cranioplasty infections: a systematic review. Neurosurgery. 2011 Apr;68(4):1124-9; discussion 1130. doi: 10.1227/NEU.0b013e31820a5470.

    PMID: 21242830BACKGROUND

  • Yang XF, Wen L, Shen F, Li G, Lou R, Liu WG, Zhan RY. Surgical complications secondary to decompressive craniectomy in patients with a head injury: a series of 108 consecutive cases. Acta Neurochir (Wien). 2008 Dec;150(12):1241-7; discussion 1248. doi: 10.1007/s00701-008-0145-9. Epub 2008 Nov 13.

    PMID: 19005615BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticStrokePostoperative HemorrhagePostoperative Complications

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression, SurgicalSurgical Procedures, OperativeCraniotomyNeurosurgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

June 11, 2017

First Posted

June 14, 2017

Study Start

January 16, 2012

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)