Effect of Craniotomy on Temporalis Function
Withdrawn before enrolling · Not applicable
Conditions studied: Pterional Craniotomy
In brief
The scientific objectives of this study are to systematically study the problems that are created by incising the attachment of the temporalis muscle in a randomized group of patients, and to determine whether another approach that does not detach the temporalis muscle results in less post-operative morbidity. Cutting through the attachment of the temporalis muscle to the skull is a widely-accepted procedure used to gain access to the skull prior to the drilling used for a pterional craniotomy (one of the most frequent types of surgeries used in neurosurgical practice). Despite the frequent use of this maneuver and the known sequelae of temporalis mobilization (e.g. post-operative myofascial pain, temporalis weakness, and pain with mastication), very little is known about the true incidence of these post-operative symptoms. Furthermore, there is very little objective evidence at the present time to support the claim that the incidence and severity of these post-operative phenomena can be decreased with use of an osteoplastic craniotomy (a procedure where the temporalis is left attached to the bony calvarium). The investigators would like to evaluate whether this slightly more time-consuming and technically demanding approach is less morbid in this respect than the contemporary pterional approach. Special note is made that the osteoplastic approach has been used in standard neurosurgical practice for quite some time.
Key facts
- Study ID
- NCT01879280
- Run by
- Vanderbilt University
- People needed
- 0
- Starts
- 2010-05-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2013-06-17
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- o The selection of participants is based solely on future plans to undergo a pterional craniotomy for resection of a tumor.
You may not qualify if…
- o Because patient feedback and participation is necessary, cognitively impaired patients are excluded from this study.
- Also, generalized cachexia, prior history of craniotomy, or any other reason for baseline temporalis asymmetry or poor wound healing is also reason for exclusion from this study.
Where it is running
- Vanderbilt Univesity Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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