This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Rectal bleeding was reported in 38.1% (24/63) of patients, 6 months after treatment, in a case series of 63 patients treated by low‑energy contact X‑ray brachytherapy (CXB) followed by external‑beam radiotherapy (EBRT) and interstitial brachytherapy boost. Bleeding lasted for up to 3 years. Patients were treated by medication or argon plasma coagulation. Only 1 patient needed occasional blood transfusions.
5.2 Authors reported that 'grade 2 rectal necrosis' occurred in 19% (12/63) of patients, at a median of 7 months after treatment, in the case series of 63 patients treated by low‑energy CXB followed by EBRT and interstitial brachytherapy boost. Details about the type of grading system for rectal necrosis were not provided. Authors stated that some patients had rectal necrosis which was accompanied by urgency and minor soiling. They highlighted that necrosis healed within 3 to 6 months in all patients.
5.3 Ulceration of the rectal mucosa was reported in 27% (27/101) of patients, at a median follow‑up of 4 months, in a case series of 101 patients treated by low‑energy CXB with or without interstitial brachytherapy boost. Ulceration healed in all these patients with no late sequelae.
5.4 Slight proctitis was reported in 10% (32/312) of patients in a case series of 312 patients treated by low‑energy CXB and interstitial brachytherapy boost. The timing of occurrence was not reported.
5.5 Moderate tenesmus, urgency of bowel movement or diarrhoea was reported in 15% (15/101) of patients, during the course of treatment, in the case series of 101 patients treated by low‑energy CXB with or without interstitial brachytherapy boost.
5.6 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: bowel perforation, rectal stenosis, recto‑vaginal fistula formation, incontinence. They considered that the following were theoretical adverse events: stricture formation, fistula formation, rectal perforation.