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Table 2 Secondary outcomes

From: Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial)

 

Usual care (n)

Restrictive strategy (n)

p

Cholecystectomy, n (%n/N)

   

 Pain-free at 12 months, n (% n/n)

   

Time to cholecystectomy in weeks, median (IQR)

   

Conservative treatment, (%n/N)

   

 Pain-free at 12 months, (% n/n)

   

Time to pain-free, median (IQR)

   

Gallstone complications, n (%n/N)

   

 Choledocholithiasis, n (%n/N)

   

 Acute cholecystitis, n (%n/N)

   

 Biliary pancreatitis, n (%n/N)

   

 Cholangitis, n (%n/N)

   

 Colic with hospitalisation, n (%n/N)

   

Gallstone complication preoperative, (% n/N)

   

Surgical complications, n (%n/N)

   

 CDC I, n (%n/N)

   

 CDC II, n (%n/N)

   

 CDC III, n (%n/N)

   

 CDC IV, n (%n/N)

   

 CDC V, n (%n/N)

   

Patient-reported satisfaction, NRS

   

Working disability

   

 Absence, hours

   

 Loss of productivity, hours

   

Non-trial related SAEs, n (%/N)

   
  1. CDC Claivien-Dindo classification, IQR interquartile range, NRS numerical rating scale, SAE serious adverse event