Critical appraisal:Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, et al 2005 2

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.

by use of computer-generated random numbers; randomisation was stratified according to participating centre and type of resection (ie, right hemicolectomy, left hemicolectomy, or sigmoidectomy). Patients were randomised by the trial coordinator (RV, who was succeeded by EK) at Erasmus University Medical Center, Rotterdam, Netherlands, and allocation was done by telephone or fax.

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.

by use of computer-generated random numbers; randomisation was stratified according to participating centre and type of resection (ie, right hemicolectomy, left hemicolectomy, or sigmoidectomy). Patients were randomised by the trial coordinator (RV, who was succeeded by EK) at Erasmus University Medical Center, Rotterdam, Netherlands, and allocation was done by telephone or fax.

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.

Neither patients nor health-care providers were blinded to patient

groupings.

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.

All excluded patients accounted for or described.

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.

Postoperative mortality; - YES

Overall morbidity; - YES
Length of operation; - YES
Length of hospital stay; - YES
Intraoperative blood loss; - YES

Fluid intake >1Ld; -
Time to first bowel movement; -
Wound infection/dehiscence; -
Bleeding; - YES
Anastomotic failure; -
Reintervention; -
Bowel obstruction; -
Analgesic use - YES

Also includes objective outcomes from: Lacy 2008 Scholin 2011 Buunen 2009 Janson 2007
These include: -
Postoperative bowel obstruction - YES
Bowel obstructions requiring surgery - YES
Disease free survival - YES
Recurrence - YES
Number of lymph nodes - YES
Hemorrhage -
Paralytic ileus -
Pneumonia -
Anastomotic dehiscence

Most mentioned specific, those not fit under morbidity or complications

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

none

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:Albert.chetcuti

Topic area

Guidelines:Colorectal cancer

Clinical question

COL1-2a-b: What is the optimal approach to resection of colorectal cancers? (a: colon)

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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