Chruscielewska 2012.
| Methods | RCT. Duration of study: participants were recruited between June 2003 and March 2006. Follow‐up: 52 weeks |
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| Participants | 122 adults with chronic radiation proctopathy or proctosigmoiditis were included if all of the following criteria were met: radiotherapy for a pelvic tumour completed at least 3 months before enrolment, the presence of rectal bleeding, radiation‐induced telangiectasia in the rectum or sigmoid, or both. The baseline characteristics of the 2 groups were comparable | |
| Interventions | Intervention: endoscopic APC followed by oral sucralfate (6 g twice daily) for 4 weeks (n = 60) Comparator: APC with placebo |
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| Outcomes | Changes in chronic radiation proctopathy severity score, changes in endoscopy scores, and complications | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer random number generator was used |
| Allocation concealment (selection bias) | Low risk | The study investigators were not involved in the preparation of the computer‐generated allocation code or in the generation of consecutively numbered containers with the study medication (drug or identical‐appearing placebo tablets) |
| Blinding (performance bias and detection bias) | Low risk | Study participants and investigators remained blinded to group assignment until the conclusion of the study, which was the visit at week 52 |
| Blinding of outcome assessment subjective | Low risk | Study participants and investigators remained blinded to group assignment until the conclusion of the study, which was the visit at week 52 |
| Blinding of outcome assessment objective | Unclear risk | Study item not assessed in the trial |
| Incomplete outcome data: subjective outcomes | Low risk | ITT analysis was used throughout the study. Only 3 dropouts in intervention group |
| Incomplete outcome data: objective outcomes | Unclear risk | Study item not assessed in the trial |
| Selective reporting (reporting bias) | Unclear risk | No registered study protocol available, however, all outcomes mentioned in the methods sections have been addressed in the results section |
| Other bias | Low risk | No indications of other bias |