Abstract
The aim of this double-blind randomised controlled trial was to evaluate the feasibility
of a study to compare differences using electromyographic (EMG) or nerve conduction
studies (NCS), questionnaires completed by patients, and range of movement, after
selective supraomohyoid neck dissection in patients with and without level IIb for
node-negative oral cancer. Between January 2006 and July 2008 we recruited 57 previously
untreated consecutive patients with node-negative T1 or T2 squamous cell carcinomas
(SCC) of the anterior two-thirds of the tongue and floor of the mouth. Thirty-eight
patients were randomised (32 unilateral and 6 bilateral dissections) into two groups.
Preoperatively and at 6 weeks postoperatively we collected EMG or NCS data on trapezius
muscle activity (primary outcome), the University of Washington quality of life scale
(UWQoLv4), the neck dissection impairment index (NDII), and range of movement. At
6 months data on range of movement and data from the questionnaires were obtained.
There was a greater mean fall in trapezius M-response amplitude for those who had
IIb dissected, which suggested that inclusion of this level caused additional morbidity.
However, it was not significant for patients who had unilateral dissections or for
all necks combined. Changes in M-amplitude from baseline to 6 weeks, and from baseline
to 6 months were strongly associated with changes in the shoulder domain of the UWQoL
and the NDII, but were less strong for change in range of movement. This feasibility
study has shown that a randomised controlled trial (RCT) is achievable. The combination
of EMG or NCS with questionnaire data preoperatively and to 6 weeks would suffice
and would simplify a new study design.
Keywords
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Article info
Publication history
Published online: October 13, 2011
Accepted:
September 7,
2011
Identification
Copyright
© 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
