Table 1

Secondary outcomes in the NEAPE trial

Secondary outcomeMeasurement variableAnalysis metricSummary measureTime point (months)
Physical performanceTST valueChange from baselineProportion3, 6 and 12
Primary wound healingSWAS scoreFinal valueProportion3
ComplicationsClavien-Dindo gradeFinal valueProportion3, 6 and 12
Persistent perineal sinus/fistulaClinical assessment categorisationFinal valueProportion3, 6 and 12
Ability to sitClinical assessment categorisationFinal valueProportion3, 6 and 12
Pain and discomfortVAS scoreChange from baseline and
spot measure
Median3, 6 and 12
Quality of lifeEQ-5D summation scoreChange from baseline and spot measureMedian3, 6 and 12
Quality of lifeEORTC-C30 domain scoresChange from baseline and spot measureMedian3, 6 and 12
Quality of lifeEORTC-CR29 domain scoresChange from baseline and spot measureMedian3, 6 and 12
Length of hospital stayTotal days in-hospitalFinal valueMedianAt discharge
Costs of surgical treatmentExpenses converted to US$Final valueMedian12
Quality-adjusted life yearsQuality-adjusted life yearsFinal valueMedian12
Local recurrenceClinical assessment categorisationFinal valueProportionEntire study period
  • EQ-5D, EuroQol-5D; NEAPE, Nordic Extended Abdominoperineal Excision; SWAS, Southampton Wound Assessment Scale; TST, timed-stands test; VAS, Visual Analogue Scale.