Abstract
One of the big controversies in colorectal cancer research is whether complete mesocolic excision (CME) offers a benefit for patients with carcinoma of the right colon or whether it might even harm these patients. A randomized trial to clarify this question has often been advocated. However, setting up such a trial is hampered by a major problem, which is mainly related to the difficulty of defining a standardized control group. First, there is no consensus of a standard non-CME hemicolectomy. Second, a surgeon who has been trained for CME will perform a “standard” right hemicolectomy differently than before. It won’t be the traditional hemicolectomy but a 5/6 CME-hemicolectomy, thus making it very difficult to detect a difference. Our approach to answering the question was a multicenter, non-randomized, registry-based trial with centralized assessment of the entire specimen. This trial has just closed recruitment after enrolling more than 1000 patients, so that long-term results can be expected in a few years.
Zusammenfassung
Eine der großen Kontroversen in der kolorektalen Chirurgie besteht in der Frage, ob eine komplette mesokolische Exzision (CME) zu einer Prognoseverbesserung führt. Zur Klärung dieser Frage wurde schon vielfach eine randomisierte Studie gefordert. Allerdings wäre eine solche Studie hauptsächlich aufgrund einer schwer zu definierenden Kontrollgruppe problematisch. Zum einen gibt es keine anerkannte Definition einer Standardhemikolektomie rechts, zum anderen würde ein Training der Chirurgen für die CME die Durchführung der Standardhemikolektomie stark beeinflussen. Das Ergebnis wäre ähnlich einer 5/6-CME, deren Unterlegenheit kaum nachweisbar wäre. Die Autoren haben sich daher entschlossen, einen Ansatz mit einer multizentrischen, nichtrandomisierten, registerbasierten Studie mit zentraler Aufarbeitung der Präparate zu wählen. Für diese Studie wurde gerade die Rekrutierung von über 1000 Patienten abgeschlossen. Langzeitergebnisse sind in einigen Jahren zu erwarten.
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S. Benz, I. Stricker, Y. Tam, and A. Tannapfel declare that they have no competing interests.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. The protocol was approved by the ethics board of the “Landesärztekammer Baden-Württemberg” (2009-118-f).
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Benz, S., Stricker, I., Tam, Y. et al. CME or traditional surgery for right-sided colon cancer?. coloproctology 39, 184–189 (2017). https://doi.org/10.1007/s00053-017-0158-z
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DOI: https://doi.org/10.1007/s00053-017-0158-z