Jensen 1997.
Methods | RCT. Duration of study: not reported Follow‐up, days (mean): 770 versus 704. However, major outcomes were compared at 12 months after randomisation |
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Participants | 21 people with CRP, RT 2 years ago, failed medical treatment, and per rectum bleeds at least 3 times a week Sex (M/F): 18/3 Similar groups with respect to demographic and clinical characteristics Dropouts: none |
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Interventions | Intervention: Heater probe (9) Comparator: Bipolar electrocoagulation probe (12) Treatment with the same probe till the bleeding stopped, mean 4 treatments |
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Outcomes | Sigmoidoscopies 4 to 6 weekly till bleeds stopped and follow‐up requirements Fall in severe bleeds and the need for follow‐up in both groups. Significant decrease in both groups | |
Notes | No side effects reported. QoL informally assessed with participant responses, which improved with treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method not described |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding (performance bias and detection bias) | Low risk | Unclear whether participants had been blinded, but as both arms received a similar active intervention it seems unlikely that this would have introduced performance bias |
Blinding of outcome assessment subjective | Low risk | Unclear whether participants had been blinded, but as both arms received a similar active intervention it seems unlikely that this would have introduced bias for subjective outcomes |
Blinding of outcome assessment objective | Unclear risk | Managing physician was blinded to treatment, however, it was not clearly described whether the research nurse who evaluated and followed all participants was blinded. |
Incomplete outcome data: subjective outcomes | Low risk | No loss to follow‐up |
Incomplete outcome data: objective outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Study was published in 1997, so no study protocol available. However, all outcomes prespecified in the methods section were reported in the results section |
Other bias | Low risk | No indications of other bias |