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
About this trial
This is an interventional treatment trial for Brain Edema focused on measuring Decompressive craniectomy, Brain Edema
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
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
NCT ID
NCT02594137
First Posted
October 29, 2015
Last Updated
October 30, 2015
Sponsor
Hospital of the Restoration, Recife
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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