Primary outcome‐lymphoedema development
lymphoedema, Lymphoedema
LYMPHOEDEMA, LYMPHOEDEMA
There was no difference in the proportion of patients who developed lymphoedema within 12 or 24 months in the No sleeve group (18 (26%) and 25 (41%) respectively) compared to the Sleeve group (11 (17%) and 18 (30% respectively:For the subgroup who developed lymphoedema, Median (IQR) time to lymphoedema was 4.5 months (1, 17.5) for patients in the No sleeve arm, and 9.9 months (6, 15) for patients randomised to Sleeve. The Kaplan–Meier time‐to‐lymphoedema curves did not differ between groups in the Intention to treat and perprotocol analyses ((A) Lymphoedema Free Survival at 60 months. (B) Per protocol analysis of Lymphoedema Free Survival. (C) Functional (FWB) and Emotional Well‐being (EWB) changes between Groups FACT‐B. Median and interquartile range are shown. (D) Emotional Well‐being (EWB) changes between the groups. Median and interquartile range are shownA total of 33 patients randomised to the ‘no sleeve’ group had a sleeve applied within 24 months;18 received the sleeve after measuring RAVI > 9%, 1 was lost to follow‐up and the remaining 13 patients had a sleeve applied before measuring RAVI > 9%.In the per‐protocol analysis, 13 patients randomised to No sleeve were included as having received a Sleeve, with time‐to‐lymphoedema measured from the date the Sleeve was applied. Thirtyseven percent of the No sleeve patients (22/60) and 27% (22/81) of the per protocol sleeve patients developed lymphoedema within 24‐months. Similarly, 40% in the No sleeve group and 30% in the Sleeve group developed lymphoedema within 5‐years (Table Incidence of Lymphoedema in per protocol analysis (RAVI ≥10% after Randomisation)
Body mass index (BMI) greater than 25 was present in 66% patients recruited to the trial. During the trial, the average change in BMI was a gain of 0.14 kg/m