A Comparison Between Two Techniques for Performing Decompressive Craniectomy

NCT02594137 | Completed DMC

• 1 other identifier: 0115.0.102.000-11
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Brain Edema; Craniocerebral Trauma; Infarction, Middle Cerebral Artery

Keywords

Decompressive craniectomy; Brain Edema

Outcome Measures

Primary Outcomes (1)

• Surgical Complications

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

  From surgical procedure until hospital discharge or death (maximum of 90 days)

Secondary Outcomes (3)

• Clinical Outcome (Analyzed by the Glasgow Outcome Scale)

  From surgical procedure until hospital discharge or death (maximum of 90 days)

• Hospital Costs

  From surgical procedure until hospital discharge or death (maximum of 90 days)

• Surgical Time

  From skin incision until closure is completed (maximum of 4 hours)

Study Arms (2)

Without Watertight Duraplasty

EXPERIMENTAL

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.

Procedure: Without watertight duraplasty

With Watertight Duraplasty

NO INTERVENTION

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.

Interventions

Without watertight duraplasty PROCEDURE

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.

Without Watertight Duraplasty

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital of the Restoration, Recife: lead

Related Publications (6)

• 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.

  PMID: 20113157 BACKGROUND

• 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.

  PMID: 18981842 BACKGROUND

• 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.

  PMID: 20707618 BACKGROUND

• 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.

  PMID: 20568936 BACKGROUND

• 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.

  PMID: 23752906 BACKGROUND

• 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.

  PMID: 29148904 DERIVED

MeSH Terms

Conditions

Brain Edema; Craniocerebral Trauma; Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Eduardo V Carvalho Junior, MD

  Hospital of the Restoration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence of Neurological Surgery

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 2, 2015

Record last verified: 2015-10