Craniofacial Surgery Perioperative Registry



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:March 2008
End Date:June 2013
Contact:Paul A Stricker, MD
Email:strickerp@email.chop.edu
Phone:215-590-1876

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Craniofacial reconstruction procedures are undertaken in young children to improve
appearance, prevent functional disturbances, and enhance psychosocial development. These
procedures involve wide scalp dissections and multiple osteotomies and have been associated
with significant morbidity. The most commonly seen perioperative complications are
associated with the rate and extent of blood loss. This prospective observational registry
will be a research tool which will provide a means to evaluate perioperative management of
these children at CHOP.


Craniofacial reconstructive surgery involves a surgical approach to the craniofacial region
to repair cranial vault and facial deformities. These procedures are undertaken in young
children to improve appearance, prevent functional disturbances, and enhance psychosocial
development. The surgery is extensive, often requiring wide scalp dissections and multiple
osteotomies and has been associated with significant morbidity. Reported complications
include intra-operative cardiac arrest, massive blood loss, intraoperative tracheal
extubation, venous air embolism, hypotension, coagulopathy, bradycardia, postoperative
seizures, surgical site infections, facial swelling, and unplanned postoperative mechanical
ventilation. The most severe and commonly seen problems are associated with the rate and
extent of blood loss. Studies report estimated blood loss to average between 60% and 100%
of the patient's estimated blood volume, with a range of 20-500%.(Hildebrandt et al 2007)
The accurate and timely estimation of blood loss is very difficult and results in imprecise
quantitative and qualitative replacement. Clinically important hypotension, metabolic
acidosis, anemia, polycythemia, dilutional coagulopathy, cardiac arrest, and death are all
related to blood loss. The creation of this prospective observational registry will provide
a means to describe the incidence of these and other clinically important perioperative
problems.

Inclusion Criteria:

1. Males or females with ages from birth to 18 years.

2. Patients undergoing surgical procedures on the craniofacial region performed by
plastic surgeons, neurosurgeons, or by plastic surgeons in concert with
neurosurgeons.

3. Patients undergoing plastic surgical procedures involving a craniotomy, craniectomy,
maxillofacial osteotomy, strip craniectomy, or other plastic surgical procedure
involving bones of the head and face.

4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Patients undergoing craniofacial plastic surgical procedures not involving bones of
the head and face.

2. Patients not admitted to the intensive care unit following surgery.

3. Patients undergoing procedures only involving the mandible.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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