We performed power calculations before the start of the study.
If 10% of the patients in the intervention group and 30% of the
patients in the control group developed arm lymphoedema
during the first year after the surgery and we applied a power
of 80% and α of 0.05, we would need a minimum of 146
patients. Taking into account the dropouts (10%), we had to
include 160 patients. Two studies have reported a cumulative
incidence rate of lymphoedema of 26% (160/631 patients with
breast cancer)13 and 40% (125/287 patients with breast cancer)8
12 and 18 months after the surgery, which is comparable with
our estimated rate for the control group. As no previous studies
have examined the additional effect of manual lymph drainage
on the prevention of arm lymphoedema, we discussed the effect
with experienced physical therapists, and they considered that
only 10% of the patients receiving guidelines, exercise therapy,
and manual lymph drainage would develop arm lymphoedema
during the first year after surgery
We performed power calculations before the start of the study.If 10% of the patients in the intervention group and 30% of thepatients in the control group developed arm lymphoedemaduring the first year after the surgery and we applied a powerof 80% and α of 0.05, we would need a minimum of 146patients. Taking into account the dropouts (10%), we had toinclude 160 patients. Two studies have reported a cumulativeincidence rate of lymphoedema of 26% (160/631 patients withbreast cancer)13 and 40% (125/287 patients with breast cancer)812 and 18 months after the surgery, which is comparable withour estimated rate for the control group. As no previous studieshave examined the additional effect of manual lymph drainageon the prevention of arm lymphoedema, we discussed the effectwith experienced physical therapists, and they considered thatonly 10% of the patients receiving guidelines, exercise therapy,and manual lymph drainage would develop arm lymphoedemaduring the first year after surgery
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