Author's reply: A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.

نویسنده

  • Rebeca M Plank
چکیده

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sample size was planned, was the trial registration document erroneous, and most importantly is there a third arm still unpublished?

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.

BACKGROUND Male circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings. METHODS We performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devi...

متن کامل

Implementation and Operational Research: A Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in Zimbabwe

BACKGROUND Early infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. METHODS Between January and June 2013, eligible infants were randomized to EIMC through ei...

متن کامل

A comparison of the Mogen and Gomco clamps in combination with dorsal penile nerve block in minimizing the pain of neonatal circumcision.

OBJECTIVES 1) To compare the Mogen and Gomco clamps with regard to pain experienced during neonatal circumcision, and 2) to assess neonatal circumcision pain with and without dorsal penile nerve block (DPNB). DESIGN/METHODS A randomized, controlled, nonblinded clinical trial; 48 healthy, full-term infants were randomized into one of the following four groups: Gomco vs Mogen with (+) or withou...

متن کامل

Estimating the Cost of Early Infant Male Circumcision in Zimbabwe: Results From a Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp

BACKGROUND Safe and cost-effective programs for implementing early infant male circumcision (EIMC) in Africa need to be piloted. We present results on a relative cost analysis within a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. METHODS Between January and June 2013, male infants who met inclusion criteria were randomized to EIMC through...

متن کامل

Analgesia for infants’ circumcision

Male circumcision (MC) is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons.Our aim is to examine and compare the various methods of analgesia and different surgical procedures reported in literature that are applied in infant MC. We performe...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • Journal of acquired immune deficiency syndromes

دوره 64 2  شماره 

صفحات  -

تاریخ انتشار 2013