Methods | RCT Accrual dates: Jan 1995 to March 2001 Setting: teaching hospital Follow‐up: 64 to 79 months |
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Participants | 326 participants (177 men and 149 women) who had had curative resection for colorectal cancer Stratified for location (colon or rectum) and Dukes' stage. Dukes' A: 53 Dukes' B: 186 Dukes' C: 93 Country: China |
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Interventions | Experimental arm: colonoscopy at each visit Control arm: colonoscopy at six months, , 30 months, and 60 months from randomisation |
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Outcomes |
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Notes | All participants had clinic visits 3/12 for 12/12, 6/12 for 24/12, then 12/12 for 24/12. At each visit, history and examinationwas performed, as well as CEA, CXR, and liver imaging (CT or US). In each group, more investigations and examinations were performed if symptomatic. Curative resection: no macroscopic residual and clear pathological margins All recurrences were confirmed histologically. Local recurrence were divided into anastomotic (intraluminal recurrence within 5 cm of the initial primary) and extraluminal. Metachronous: second primary colorectal cancer after exclusion of a synchronous primary by a preoperative colonoscopy or within 6 months postoperatively Salvage surgery was considered curative when all macroscopic was removed and pathological margins were clear. doi: 10.1016/j.gie.2008.05.017 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (page 610): "The patients were then randomized to either the RCS group or the ICS group by means of sealed envelopes containing cards printed with ICS or RCS within each stratum." Comment: the paper gave insufficient details of the randomisation process. |
Allocation concealment (selection bias) | Unclear risk | Quote (page 610): "Sealed envelopes containing cards printed with ICS or RCS within each stratum..." Comment: there is insufficient detail given to be sure that allocation concealment was truly concealed; it is not stated who performed the randomisation and if the envelopes were opaque. |
Blinding of participants and personnel | High risk | The study did not mention blinding of participants or personnel. Participants in the control arm may have been more likely to report symptoms knowing that they were not having colonoscopies. |
Blinding of outcome assessment | High risk | Quote (page 610): "More complete and systematic examinations were performed whenever a patient in either group had symptoms suggestive of a possible recurrence of the disease (e.g. abdominal or perineal pain, altered bowel movements, change in fecal colour, weight loss)." Comment: lack of blinding may have introduced bias with assessment of reported symptoms or signs, perhaps making further investigation more likely in the control group. |
Incomplete outcome data (attrition and exclusions) | Unclear risk | Quote (page 611): "Seven patients (ICS, 4; RCS, 3) were lost during the follow‐up period." Comment: the paper gave no details about why they were lost to follow‐up, which may introduce bias. |
Selective reporting (reporting bias) | Unclear risk |
Outcomes stated in the paper
Outcomes reported
We did not have access to the study protocol, so rated the risk of bias for this outcome as unclear. |
Other sources of bias | Unclear risk | We detected no other bias. |