Acute radiation dermatitis is a frequent adverse effect of radiotherapy and commonly affects the perianal skin in patients treated for rectal cancer. The literature and clinical attention have emphasized perianal skin injury, while injury localized to the anal canal skin has been less well described. Patients with anal canal radiation dermatitis most commonly report anal pain, which can substantially reduce daily functioning and quality of life.
Dressings such as Mepilex Lite have been recommended for management of acute radiation dermatitis and are reported to be effective for superficial skin injuries. However, evidence on their use specifically for radiation-induced dermatitis of the anal canal skin is limited. This trial aims to evaluate the clinical efficacy and safety of combining Mepilex Lite dressings with rectal indomethacin suppositories compared with indomethacin alone for this indication.
This is an assessor-blinded randomized controlled trial. The study will be conducted in the tumour radiotherapy ward of the First Affiliated Hospital of Shandong First Medical University. The design compares two parallel groups allocated 1:1 and includes predefined assessment time points at baseline and days 7, 14 and 21 after intervention.
A total of 274 eligible patients will be enrolled. The source document reports that these participants will be recruited from the hospital’s radiotherapy ward. Specific inclusion and exclusion criteria beyond eligibility for the trial were not detailed in the source summary.
Participants will be randomly assigned to either the experimental group or the control group in a 1:1 ratio. The trial is described as assessor-blinded; the source does not provide further operational details on allocation concealment or who exactly is blinded (for example, clinicians, patients or outcome assessors), so those procedural details are not reported here.
Control group: Participants allocated to the control group will receive rectal administration of 30 mg indomethacin suppositories. The source states this as the standard measure applied to the control arm.
Experimental group: Participants in the experimental arm will receive the same rectal 30 mg indomethacin suppositories plus application of a Mepilex Lite dressing to the anal canal skin. The dressing specified is 5 cm × 5 cm and will be inserted into the anal canal 3 cm through the anus with 2 cm left exposed. The source does not report frequency of dressing changes, duration of each application beyond the exposure described, or any additional local care measures.
Primary outcome: The main outcome indicator is the treatment efficiency of acute radiation dermatitis of the anal canal skin measured on day 14 after the intervention. The source summary does not define the exact criteria or scale used to determine "treatment efficiency," so those operational definitions were not reported.
Secondary outcomes: Secondary outcome indicators are the treatment efficiency of anal canal radiation dermatitis on days 7 and 21 after intervention.
The trial will capture patient-reported outcomes using validated instruments at baseline and on days 7, 14 and 21 post-intervention. The measures include:
A table questionnaire survey will be administered at the specified time points to collect these measures. The source does not provide thresholds, scoring approaches, or analytic plans for these instruments.
Ethical approval for the study protocol was obtained from the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (approval number: YXLL-KY-2024 (162)). The investigators plan to publish results in peer-reviewed journals and present findings at domestic and international conferences. The trial is registered with ClinicalTrials.gov under number NCT06837831.
The source summary provides core design elements, intervention descriptions and outcome time points, but omits operational details such as precise eligibility criteria, randomisation procedures, blinding logistics, definitions of "treatment efficiency," dressing change frequency, and statistical analysis plans. Those procedural and analytic details were not reported in the provided source text and therefore are not included here.