The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]

<p>Abstract</p> <p>Background</p> <p>Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Recent studies, primarily observational, h...

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Main Authors: Boodhwani Munir, Nathan Howard J, Lam B Khanh, Rubens Fraser D
Format: Article
Language:English
Published: BMC 2006-01-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/7/1/1
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spelling doaj-a8e8a487c55d4f42b33b39782d6a84e92020-11-25T00:14:31ZengBMCTrials1745-62152006-01-0171110.1186/1745-6215-7-1The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]Boodhwani MunirNathan Howard JLam B KhanhRubens Fraser D<p>Abstract</p> <p>Background</p> <p>Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Recent studies, primarily observational, have suggested that skeletonization of the ITA can improve conduit flow, increase length, and reduce the risk of deep sternal infection in high risk patients. Furthermore, skeletonization of the ITA can potentially preserve intercostal nerves and reduce post-operative pain and dysesthesias associated with ITA harvesting. In order to assess the effects of ITA skeletonization, we report a prospective, randomized, within-patient study design that shares many features of a cross-over study.</p> <p>Methods</p> <p>Patients undergoing bilateral internal thoracic artery harvest will be randomized to having one side skeletonized and the other harvested in a non-skeletonized manner. Outcome measures include ITA flow and length measured intra-operatively, post-operative pain and dysesthesia, evaluated at discharge, four weeks, and three months post-operatively, and sternal perfusion assessed using single photon emission computed tomography. Harvest times as well as safety endpoints of ITA injury will be recorded.</p> <p>Discussion</p> <p>This study design, using within-patient comparisons and paired analyses, minimizes the variability of the outcome measures, which is seldom possible in the evaluation of surgical techniques, with minimal chance of carryover effects that can hamper the interpretation of traditional cross-over studies. This study will provide a valid evaluation of clinically relevant effects of internal thoracic artery skeletonization in improving outcomes following coronary artery bypass surgery.</p> http://www.trialsjournal.com/content/7/1/1
collection DOAJ
language English
format Article
sources DOAJ
author Boodhwani Munir
Nathan Howard J
Lam B Khanh
Rubens Fraser D
spellingShingle Boodhwani Munir
Nathan Howard J
Lam B Khanh
Rubens Fraser D
The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]
Trials
author_facet Boodhwani Munir
Nathan Howard J
Lam B Khanh
Rubens Fraser D
author_sort Boodhwani Munir
title The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]
title_short The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]
title_full The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]
title_fullStr The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]
title_full_unstemmed The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]
title_sort internal thoracic artery skeletonization study: a paired, within-patient comparison [nct00265499]
publisher BMC
series Trials
issn 1745-6215
publishDate 2006-01-01
description <p>Abstract</p> <p>Background</p> <p>Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Recent studies, primarily observational, have suggested that skeletonization of the ITA can improve conduit flow, increase length, and reduce the risk of deep sternal infection in high risk patients. Furthermore, skeletonization of the ITA can potentially preserve intercostal nerves and reduce post-operative pain and dysesthesias associated with ITA harvesting. In order to assess the effects of ITA skeletonization, we report a prospective, randomized, within-patient study design that shares many features of a cross-over study.</p> <p>Methods</p> <p>Patients undergoing bilateral internal thoracic artery harvest will be randomized to having one side skeletonized and the other harvested in a non-skeletonized manner. Outcome measures include ITA flow and length measured intra-operatively, post-operative pain and dysesthesia, evaluated at discharge, four weeks, and three months post-operatively, and sternal perfusion assessed using single photon emission computed tomography. Harvest times as well as safety endpoints of ITA injury will be recorded.</p> <p>Discussion</p> <p>This study design, using within-patient comparisons and paired analyses, minimizes the variability of the outcome measures, which is seldom possible in the evaluation of surgical techniques, with minimal chance of carryover effects that can hamper the interpretation of traditional cross-over studies. This study will provide a valid evaluation of clinically relevant effects of internal thoracic artery skeletonization in improving outcomes following coronary artery bypass surgery.</p>
url http://www.trialsjournal.com/content/7/1/1
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