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01.12.2006 | Study protocol | Ausgabe 1/2006 Open Access

Trials 1/2006

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

Zeitschrift:
Trials > Ausgabe 1/2006
Autoren:
Munir Boodhwani, Howard J Nathan, B Khanh Lam, Fraser D Rubens
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1745-6215-7-1) contains supplementary material, which is available to authorized users.

Competing interests

The author(s) declare that they have no competing interests.

Authors' contributions

MB, HJN, and FDR were responsible for the design of the study. BKL and FDR will be performing the study interventions.

Abstract

Background

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.

Methods

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.

Discussion

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.
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