Effect of Craniotomy on Temporalis Function

Pterional Craniotomy Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01879280
• Other study ID #: 100387
• Status: Withdrawn
• Phase: N/A
• First received: April 29, 2010
• Last updated: June 12, 2013
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In contemporary neurosurgery, when performing a pterional craniotomy, neurosurgeons have been taught to cut through and detach the temporalis before drilling the skull to "turn a bone flap". While there are ways to turn a bone flap with the temporalis still attached (i.e., an "osteoplastic craniotomy"), this is thought to be slightly more time-consuming and is used less often in many centers. Additionally, there is a common misconception that osteoplastic craniotomy does not allow an equivalent view, although recent evidence suggests that the surgical exposure in the two approaches is no different. Aside from the extra time involved, we do not feel that leaving the temporalis attached to the bony calvarium disadvantages the patient in any fashion (and—in fact—may result in less post-operative morbidity). We are interested in this project because there is actually very little objective data regarding the morbidity people experience when the temporalis muscle is cut and mobilized prior to drilling the skull. If, in this study, we find that the group randomized to traditional pterional craniotomy experiences significantly more morbidity than the group randomized to osteoplastic craniotomy, this may justify conversion to an osteoplastic craniotomy in many or all instances.

We wish to quantify the morbidity that is associated with the specific methods used to detach the temporalis muscle from the skull. Many variables regarding the way the temporalis is detached will be recorded and assessed in the group randomized to traditional pterional craniotomy. Additionally, many methods will be used to measure post-operative temporalis atrophy and/or dysfunction in the two randomized groups. After post-operative morbidity has been quantified, we plan to compare the traditional pterional group to the osteoplastic group and assess for significance.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• o The selection of participants is based solely on future plans to undergo a pterional craniotomy for resection of a tumor.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterional Craniotomy

Intervention

Procedure:
• Traditional pterional craniotomy
In the standard pterional craniotomy group, the attachment of the temporalis will be cut and the temporalis will be mobilized prior to exposure of the underlying bony calvarium. This maneuver is currently accepted for use by the majority of neurosurgeons nationwide.
• Osteoplastic craniotomy
In the osteoplastic group, the temporalis will be left attached to the bony calvarium prior to exposure of the tumor. There are ways to turn a bone flap with the temporalis still attached (i.e., an "osteoplastic craniotomy"). However, this method is thought to be slightly more time-consuming and is used less often in many centers. Aside from the extra time involved, we do not feel that leaving the temporalis attached to the bony calvarium disadvantages the patient in any fashion and may--in fact--result in less post-operative morbidity.

Locations

Country	Name	City	State
United States	Vanderbilt Univesity Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Balasingam V, Noguchi A, McMenomey SO, Delashaw JB Jr. Modified osteoplastic orbitozygomatic craniotomy. Technical note. J Neurosurg. 2005 May;102(5):940-4. — View Citation

de Andrade Júnior FC, de Andrade FC, de Araujo Filho CM, Carcagnolo Filho J. Dysfunction of the temporalis muscle after pterional craniotomy for intracranial aneurysms. Comparative, prospective and randomized study of one flap versus two flaps dieresis. A — View Citation

Rocha-Filho PA, Fujarra FJ, Gherpelli JL, Rabello GD, de Siqueira JT. The long-term effect of craniotomy on temporalis muscle function. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Nov;104(5):e17-21. Epub 2007 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative mobility of the jaw (e.g. lateral excursion and protrusion)	Data regarding baseline and post-operative range-of-motion of the mouth will be collected before and after surgery.	6 weeks and 1 year post-operatively	Yes
Secondary	Post-operative pain with chewing	Data regarding baseline and post-operative pain with chewing will be obtained at 6 months and 1 year.	6 weeks and 1 year	No
Secondary	Post-operative cosmesis of the temporal region	Data regarding baseline and post-operative cosmesis will be obtained and 6 weeks and 1 year post-operatively.	6 weeks and 1 year post-operatively	No

External Links

•   paper #3