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Table 6 An example of a surgical randomised controlled trial (RCT) in which the surgical interventions were questioned following publication of the trial

From: Interventions in randomised controlled trials in surgery: issues to consider during trial design

Trial features

 

Journal, year of publication

Lancet, 2009

Aim of RCT

To compare survival between standard or minimally invasive surgery in patients with colorectal cancer [28].

Main findings

The survival rate following minimally invasive surgery was non-inferior to standard surgery

Verbatim description of the surgical intervention

The following description was provided for both open and minimally invasive surgery: ‘Resection involved the division of blood vessels and bowel’. Conversion to open surgery was defined as a ‘vertical incision’. No other description regarding the incisions was provided.

Published correspondence

‘What about right-sided cancers? It is well known among laparoscopic surgeons that ‘laparoscopic’ right colectomy can in fact mean three different kinds of procedures: a true or totally laparoscopic right colectomy (with both dissection and anastomosis done intra-corporeally), laparoscopically assisted colectomy (with only the vascular ligation done intra-corporeally), or so-called laparoscopic colectomy (with only the colonic dissection done laparoscopically). The authors of the CLASICC trial stated only that resection involved ‘(where possible) the division of blood vessels and bowel’. Conversion was defined as a ‘vertical incision’, but what about (for example) a transverse incision of almost 7 cm in a thin patient allowing both division of vessels and bowel after a simple laparoscopic colonic mobilisation? Is that procedure laparoscopic or open? Since the actual procedure is not specified, the external validity of trials regarding the laparoscopic approach for right-sided colon cancers should be questioned [34].’