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A Comparison Between Two Techniques for Performing Decompressive Craniectomy

Primary Purpose

Brain Edema, Craniocerebral Trauma, Infarction, Middle Cerebral Artery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Without watertight duraplasty
Sponsored by
Hospital of the Restoration, Recife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Edema focused on measuring Decompressive craniectomy, Brain Edema

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to the Neurotrauma Service of the Hospital of Restoration from January 2012 to December 2013, age range 18 to 60 years old and with clinical indication for decompressive craniectomy.

Exclusion Criteria:

  • Indication for bifrontal decompressive craniectomy.
  • Indication for Posterior Fossa decompressive craniectomy
  • Patients with intra-axial contusions or hematomas requiring surgical evacuation in which case injury to the arachnoid could lead to an increased risk of cerebrospinal fluid leak

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Without Watertight Duraplasty

    With Watertight Duraplasty

    Arm Description

    After standard craniectomy (12x15cm) and dural opening, the "intervention", which is to not perform watertight duraplasty is carried out. The exposed brain parenchyma is covered with Surgicel. Usual closure is then performed.

    After standard craniectomy (12x15cm) and dural opening, watertight duraplasty with pericranium or an artificial graft is performed. Usual closure is then performed. This kind of duraplasty is performed by most neurosurgeons and this group will be used as a control.

    Outcomes

    Primary Outcome Measures

    Surgical Complications
    Cerebrospinal Fluid Leaks, Wound Infection, Brain Abscess, Subgaleal Fluid Collections)

    Secondary Outcome Measures

    Clinical Outcome (Analyzed by the Glasgow Outcome Scale)
    Hospital Costs
    Surgical Time

    Full Information

    First Posted
    October 29, 2015
    Last Updated
    October 30, 2015
    Sponsor
    Hospital of the Restoration, Recife
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02594137
    Brief Title
    A Comparison Between Two Techniques for Performing Decompressive Craniectomy
    Official Title
    A Randomized Controlled Study Comparing 2 Surgical Techniques for Decompressive Craniectomy: With Watertight Duraplasty Versus Without Watertight Duraplasty.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital of the Restoration, Recife

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare two surgical techniques for a neurosurgical procedure used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy).
    Detailed Description
    After clinical indication for unilateral decompressive craniectomy (DC), patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) vs. without watertight duraplasty / rapid closure DC (test group). In all cases, a large trauma flap (i.e. large reverse question mark starting from the tragus and extending to the midline) was performed. Skin, galea and muscle layers were elevated according to surgeon preference. Thus a wide (at least 12x15cm) craniotomy was performed and the temporal bone was removed until flush with the middle fossa floor. After dural opening, watertight duraplasty with pericranium or an artificial graft (at surgeon's discretion) was performed in the control group, while no watertight duraplasty was performed in the test group, and exposed brain parenchyma was covered with Surgicel®. Usual closure was then performed. Patients were then monitored daily by evaluators blinded to the randomization (control or test group) from the date of surgery until hospital discharge or death.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Edema, Craniocerebral Trauma, Infarction, Middle Cerebral Artery
    Keywords
    Decompressive craniectomy, Brain Edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Without Watertight Duraplasty
    Arm Type
    Experimental
    Arm Description
    After standard craniectomy (12x15cm) and dural opening, the "intervention", which is to not perform watertight duraplasty is carried out. The exposed brain parenchyma is covered with Surgicel. Usual closure is then performed.
    Arm Title
    With Watertight Duraplasty
    Arm Type
    No Intervention
    Arm Description
    After standard craniectomy (12x15cm) and dural opening, watertight duraplasty with pericranium or an artificial graft is performed. Usual closure is then performed. This kind of duraplasty is performed by most neurosurgeons and this group will be used as a control.
    Intervention Type
    Procedure
    Intervention Name(s)
    Without watertight duraplasty
    Intervention Description
    After standard craniectomy and dural opening, provided there is no brain contusions or hematomas requiring surgical evacuation, no watertight duraplasty is performed. The dura is left opened and the brain parenchyma is covered with Surgicel. Usual closure is then performed.
    Primary Outcome Measure Information:
    Title
    Surgical Complications
    Description
    Cerebrospinal Fluid Leaks, Wound Infection, Brain Abscess, Subgaleal Fluid Collections)
    Time Frame
    From surgical procedure until hospital discharge or death (maximum of 90 days)
    Secondary Outcome Measure Information:
    Title
    Clinical Outcome (Analyzed by the Glasgow Outcome Scale)
    Time Frame
    From surgical procedure until hospital discharge or death (maximum of 90 days)
    Title
    Hospital Costs
    Time Frame
    From surgical procedure until hospital discharge or death (maximum of 90 days)
    Title
    Surgical Time
    Time Frame
    From skin incision until closure is completed (maximum of 4 hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients admitted to the Neurotrauma Service of the Hospital of Restoration from January 2012 to December 2013, age range 18 to 60 years old and with clinical indication for decompressive craniectomy. Exclusion Criteria: Indication for bifrontal decompressive craniectomy. Indication for Posterior Fossa decompressive craniectomy Patients with intra-axial contusions or hematomas requiring surgical evacuation in which case injury to the arachnoid could lead to an increased risk of cerebrospinal fluid leak
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduardo V Carvalho Junior, MD
    Organizational Affiliation
    Hospital of the Restoration
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20113157
    Citation
    Guresir E, Vatter H, Schuss P, Oszvald A, Raabe A, Seifert V, Beck J. Rapid closure technique in decompressive craniectomy. J Neurosurg. 2011 Apr;114(4):954-60. doi: 10.3171/2009.12.JNS091065. Epub 2010 Jan 29.
    Results Reference
    background
    PubMed Identifier
    18981842
    Citation
    Barth M, Tuettenberg J, Thome C, Weiss C, Vajkoczy P, Schmiedek P. Watertight dural closure: is it necessary? A prospective randomized trial in patients with supratentorial craniotomies. Neurosurgery. 2008 Oct;63(4 Suppl 2):352-8; discussion 358. doi: 10.1227/01.NEU.0000310696.52302.99.
    Results Reference
    background
    PubMed Identifier
    20707618
    Citation
    Sade B, Oya S, Lee JH. Non-watertight dural reconstruction in meningioma surgery: results in 439 consecutive patients and a review of the literature. Clinical article. J Neurosurg. 2011 Mar;114(3):714-8. doi: 10.3171/2010.7.JNS10460. Epub 2010 Aug 13.
    Results Reference
    background
    PubMed Identifier
    20568936
    Citation
    Ragel BT, Klimo P Jr, Martin JE, Teff RJ, Bakken HE, Armonda RA. Wartime decompressive craniectomy: technique and lessons learned. Neurosurg Focus. 2010 May;28(5):E2. doi: 10.3171/2010.3.FOCUS1028.
    Results Reference
    background
    PubMed Identifier
    23752906
    Citation
    Kolias AG, Kirkpatrick PJ, Hutchinson PJ. Decompressive craniectomy: past, present and future. Nat Rev Neurol. 2013 Jul;9(7):405-15. doi: 10.1038/nrneurol.2013.106. Epub 2013 Jun 11.
    Results Reference
    background
    PubMed Identifier
    29148904
    Citation
    Vieira E, Guimaraes TC, Faquini IV, Silva JL, Saboia T, Andrade RVCL, Gemir TL, Neri VC, Almeida NS, Azevedo-Filho HRC. Randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty. J Neurosurg. 2018 Oct;129(4):1017-1023. doi: 10.3171/2017.4.JNS152954. Epub 2017 Nov 17.
    Results Reference
    derived

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    A Comparison Between Two Techniques for Performing Decompressive Craniectomy

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