- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00658242
Craniofacial Surgery Perioperative Registry
August 7, 2013 updated by: Children's Hospital of Philadelphia
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
249
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects presenting for craniofacial surgery
Description
Inclusion Criteria:
- Males or females with ages from birth to 18 years.
- Patients undergoing surgical procedures on the craniofacial region performed by plastic surgeons, neurosurgeons, or by plastic surgeons in concert with neurosurgeons.
- 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.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria:
- Patients undergoing craniofacial plastic surgical procedures not involving bones of the head and face.
- Patients not admitted to the intensive care unit following surgery.
- Patients undergoing procedures only involving the mandible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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I
Subjects having Craniofacial surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To create a research tool that prospectively captures perioperative data in the craniofacial surgical patient population that may provide insights into the perioperative management and help guide clinical decision making.
Time Frame: 2.5 years
|
2.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul A Stricker, MD, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
April 8, 2008
First Submitted That Met QC Criteria
April 11, 2008
First Posted (Estimate)
April 14, 2008
Study Record Updates
Last Update Posted (Estimate)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2008-3-5842
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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