Critical appraisal:Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, et al 2015

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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
Patients were randomized to undergo laparoscopic or open surgery at the NHMRC Clinical Trials Centre via the Internet using the method of minimization and stratified by (1) the site of the tumor (measured by rigid sigmoidoscopy and defined by location from the anal verge: high, 10-15 cm; middle, 5-10 cm; low, <5 cm), (2) the registering surgeon, (3) the planned operative procedure (low anterior resection [sphincter preserving] or abdominoperineal resection [sphincter removal]), (4) body mass index (BMI [calculated as weight in kilograms divided by height in meters squared] of <30 or ≥30), (5) preoperative radiotherapy (yes vs no), and (6) distant metastases (yes vs no).
What was the risk of bias from the random sequence generation?Jutta's question mark icon.png
Low
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
What was the risk of bias from the allocation concealment?Jutta's question mark icon.png
Unclear
Blinding
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
An audit pathologist also was blinded to the mode of surgery.
What was the risk of bias from the blinding of participants and personnel and outcome assessors?Jutta's question mark icon.png
Low
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
What was the risk of bias from incomplete outcome data?Jutta's question mark icon.png
Low
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
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
Low
Other sources of bias
Describe any other sources of biasJutta's question mark icon.png
What was the risk of bias from other sources?Jutta's question mark icon.png
Low
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.


Article
Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, et al. Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. JAMA 2015 Oct 6;314(13):1356-63 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26441180.
Assigned to
User:Albert.chetcuti
Topic area
Guidelines:Colorectal cancer
Clinical question
Form
Form:Quality appraisal rct-cochrane
Outcomes
Complications

Section below only relevant for Cancer Council Project Officer

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