Randomised controlled trial to assess and compare the performance and safety of two-piece ostomy appliances.

BACKGROUND: Choice of ostomy appliances is based on multiple factors including economic considerations, individual patient requirements and lifestyle. A recently launched two-piece ostomy collection device with an extended tape border is expected to provide a long wear time and increase patients' sense of security. AIMS AND METHODS: A randomised controlled, non-blinded, cross-over study involving 38 patients (with colostomies and ileostomies) compared the test device to a similar device from the same manufacturer but without the tape border. The main objective was to assess wear time for non-inferiority as a measure of efficacy. Secondary efficacy assessment included peristomal skin condition using the DET (discolouration, erosion and tissue growth) score and patient acceptability, which was assessed through questionnaires using Likert-scale options. Safety was assessed according to the incidence and intensity of device-related adverse events, and the condition of the peristomal skin. RESULTS AND CONCLUSION: Analysis of results in the per-protocol population showed an average wear time of 4.5 days for both devices and demonstrated non-inferiority. DET scores were similar in both groups, and both had low rates of device-related adverse events, all of which related to peristomal skin. Patients said the devices were user friendly. While the two devices are similar, some patients may find one with an adhesive tape more suited to their needs.

The Enigma of Giant Phyllodes Tumour.

Phyllodes tumours are an uncommon type of biphasic fibroepithelial neoplasm of the breast. We present a case of a 28-year-old, para one lady with no risk of breast cancer presented with painless left breast swelling for three months. Over one month, the swelling suddenly increased in size and became painful with skin changes associated with pus discharge. On physical examination, a huge swelling measuring about 25cm x 30cm occupies the central and lateral aspect of the left breast with surrounding erythema. We proceeded for a tru-cut biopsy, and the histopathological examination (HPE) showed a stromal proliferation with myxoid changes consistent with phyllodes tumour of benign type. The patient underwent a left simple mastectomy, and the histopathological examination (HPE) confirmed the diagnosis of borderline phyllodes tumour with clear margins without lymph nodes involvement. The patient was subsequently referred to the oncology team and was subjected to 40 Gy in 15 fractions of radiotherapy. Given the rarity of the disease and based on current studies, simple mastectomy with negative margins is recommended for giant benign phyllodes tumours.