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To the Editor: Dr Fitzgibbons and colleagues¹ conducted a randomized controlled trial comparing watchful waiting vs immediate repair of inguinal hernia. The authors reported similar primary outcomes in both groups and concluded that delaying surgical repair is safe.

Data can be analyzed in many ways. To maintain the effect of randomization and thus group comparability, the authors appropriately used an intent-to-treat (ITT) approach. However, assuming that crossing-over equals failure in the ITT analysis would result in immediate repair having a superior primary outcome of pain-limiting activities (50/317 [15.8%] vs 97/336 [28.9%], P<.001 by 2-sided Fisher exact test).

In addition, the percentage of patients with pain interfering with activities at 2 years was higher among patients who had delayed repair (crossing over from watchful waiting) compared with those who underwent surgical repair as assigned (7/80 [8.8%] vs 4/274 [1.5%], respectively; P = .004). However, this analysis would be difficult to interpret, . . . [Full Text of this Article]

Jean-Jacques Parienti, MD
parienti-jj@chu-caen.fr
Department of Biostatistics and Clinical Research
Côte de Nacre University Hospital
Caen, France

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