Critical appraisal:Veenhof AA, Sietses C, von Blomberg BM, van Hoogstraten IM, vd Pas MH, Meijerink WJ, et al 2011 4

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Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)

Random sequence generation
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.Jutta's question mark icon.png
In June 2006, the VU University Medical Center (VUmc) initiated participation in the COLOR II trial; a randomized study comparing laparoscopic to open TME in patients with non-metastasized rectal cancer. All patients who were randomized until December 2008 for the COLOR II trial at the VUmc were included into this sub-study.

The online protocol document details the following "Randomization for all centers will be done through the internet:"
Randomization is stratified for each participating center, planned procedure, radiotherapy and sex.

What was the risk of bias from the random sequence generation?Jutta's question mark icon.png
Allocation concealment
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of or during, enrolment.Jutta's question mark icon.png
Not described
What was the risk of bias from the allocation concealment?Jutta's question mark icon.png
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.Jutta's question mark icon.png
Not described
What was the risk of bias from the blinding of participants and personnel and outcome assessors?Jutta's question mark icon.png
Incomplete outcome data
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.Jutta's question mark icon.png
Only a small subset of 40 patients from the whole trial.
What was the risk of bias from incomplete outcome data?Jutta's question mark icon.png
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.Jutta's question mark icon.png
The primary endpoints of the study were to demonstrate differences in inflammatory response by evaluating proinflammatory cytokines (interleukin-6 and interleukin-8) and C-reactive protein (CRP); immune status by evaluating white blood cells and HLA-DR expression on monocytes; and stress response by evaluating cortisol, prolactin, and growth hormone in both groups of patients.

Mortality defined in the study protocol.

What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).Jutta's question mark icon.png
Other sources of bias
Describe any other sources of biasJutta's question mark icon.png
Selection of these 40 patients from the whole trial cohort
What was the risk of bias from other sources?Jutta's question mark icon.png
Overall risk of bias
Unclear risk of bias Additional comments: Please replace this text and include any additional comments in regards to your risk of bias rating

Jutta's tick icon.png This appraisal has been completed.

Veenhof AA, Sietses C, von Blomberg BM, van Hoogstraten IM, vd Pas MH, Meijerink WJ, et al. The surgical stress response and postoperative immune function after laparoscopic or conventional total mesorectal excision in rectal cancer: a randomized trial. Int J Colorectal Dis 2011 Jan;26(1):53-9 Available from:
Assigned to
Topic area
Guidelines:Colorectal cancer
Clinical question
Form:Quality appraisal rct-cochrane

Section below only relevant for Cancer Council Project Officer

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