Letters to the Editor
To the Editors:
I was interested in the trial published online on January 10, 2013.1 Two issues concerned me.
DISCREPANCIES BETWEEN TRIAL REGISTRATION AND THE PUBLISHED ARTICLE
The published article describes a 2-arm trial of 300 infants comparing the Mogen clamp (n = 153) with the Plastibell device (n = 147). However, the trial registration documents on ClinicalTrials.gov (NCT00971958) has, since June 24, 2011, described a 3-arm trial with the AccuCirc device added as a third arm, making a total sample size of 450. The trial registration also described the total “anticipated enrolment” initially as 1000, later increased to 1250, and currently records an “achieved enrolment” of 1020. Can the authors clarify which sample size was planned, was the trial registration document erroneous, and most importantly is there a third arm still unpublished?
THE THREE POSTCIRCUMCISION DEATHS
Three postoperative deaths out of 300 in a nontherapeutic trial in healthy newborns is alarming. I was slightly surprised that the authors did not see fit to mention them in the abstract.
We are told that the authors and the Institutional Review Boards (IRBs) judged that the deaths were unrelated to the circumcision. However, I note the use of the singular “death” in this statement:
“Of these, 2 died of gastroenteritis and one died of suspected neonatal sepsis on his second day of life, with the [singular] death reviewed by the study Data Safety Monitoring Committee, Botswana Health Research and Development Committee, and Brigham and Women's Hospital Institutional Review Board and not thought to be procedure related.” (end of para 3 under “Study Participants”).
Does this mean that only the sepsis-related death was reviewed by the IRB?
Cause of death in newborns can be difficult to ascertain, and in the absence of a “no circumcision” arm, it is impossible to prove that the deaths were unrelated. I think readers, parents, and health planners considering neonatal circumcision prograes would be interested in rather more detail. What were the ages of the children when they died and the time relation of the deaths to the surgery? Did the infants have any preexisting illness, what investigations were performed, and were autopsies done? If so, what were the findings?
1. Plank RM, Ndubuka NO, Wirth KE, et al.. A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana. J Acquir Immune Defic Syndr. 2013;62:e131–e137.