Critical appraisal:Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, et al 2005

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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
Computer-generated list used for randomisation. This list was stratified by participating centre and proposed type of resection (ie, right hemicolectomy, left hemicolectomy, or sigmoidectomy). Stratification was done by centre because all surgeons who participated in the COLOR trial work in colorectal surgery teams, instead of working as individual surgeons.
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
Randomisation was done centrally at the coordinating centre by fax or telephone

using a computer-generated list.

What was the risk of bias from the allocation concealment?Jutta's question mark icon.png
Low
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
Patients were not blinded to the procedure they were allocated because covering all possible open and laparoscopic incisions was thought too cumbersome. Healthcare providers were not blinded
What was the risk of bias from the blinding of participants and personnel and outcome assessors?Jutta's question mark icon.png
High
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
Attrition and exclusion reported with reasons and similar numbers/reasons for each group
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
Fluid intake >1Ld, Time to first bowel movement, Reintervention and Analgesic use were not pre-specified in the methods
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
High
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
High 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
Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, et al. Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 2005 Jul;6(7):477-84 Available from: http://www.ncbi.nlm.nih.gov/pubmed/15992696.
Assigned to
User:Victoria.freeman
Topic area
Guidelines:Colorectal cancer
Clinical question
Form
Form:Quality appraisal rct-cochrane
Outcomes
Objective outcomes; - Postoperative mortality; - Overall morbidity; - Fluid intake >1Ld; - Time to first bowel movement; - Wound infection/dehiscence; - Bleeding; - Anastomotic failure; - Reintervention; - Bowel obstruction; - Length of operation; - Length of hospital stay; - Intraoperative blood loss; - Analgesic use
Clinical trial
COLOR
Notes
Also includes objective outcomes from:

Lacy 2008 Scholin 2011 Buunen 2009 Janson 2007

These include: - Postoperative bowel obstruction - Bowel obstructions requiring surgery - Disease free survival - Recurrence - Number of lymph nodes - Hemorrhage - Paralytic ileus - Pneumonia - Anastomotic dehiscence

Section below only relevant for Cancer Council Project Officer

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