Critical appraisal:Veenhof AA, Sietses C, von Blomberg BM, van Hoogstraten IM, vd Pas MH, Meijerink WJ, et al 2011 4
Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)
Random sequence generation
- 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.
- Not described
- Not described
Incomplete outcome data
- Only a small subset of 40 patients from the whole trial.
Selective outcome reporting
- 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.
Other sources 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|
- 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: http://www.ncbi.nlm.nih.gov/pubmed/20922542.
- Assigned to
- Topic area
- Guidelines:Colorectal cancer
- Clinical question
- Form:Quality appraisal rct-cochrane
Section below only relevant for Cancer Council Project Officer