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.
- 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?
- 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.
- 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?
- 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.
- 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?
- 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.
- Attrition and exclusion reported with reasons and similar numbers/reasons for each group
What was the risk of bias from incomplete outcome data?
- Low
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
- 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).
- High
Other sources of bias
Describe any other sources of bias
What was the risk of bias from other sources?
- 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 |
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