Comparison of two different suction rectal biopsy forceps for the diagnosis of Hirschsprung disease in children: A randomised controlled trial

Abstract

A randomised controlled trial (RCT) will be conducted at Monash Children’s Hospital on infants less than 6 months of age with suspected Hirschsprung disease, requiring a suction rectal biopsy. The study will be an open-label (unblinded) randomised controlled trial: due to the nature of the intervention (i.e. different appearance of the rbi2® and SBT200®) biopsy forceps blinding is not possible. The hypothesis to be tested is that the SBT200® SRB forceps will have lower rates of inadequate specimen sampling, lower re-biopsy rates and lower or comparable complication rates. The proposed sample size for this trial is 40 children in total with 20 in each arm. Since the SBT200® is a brand-new device, no data is available regarding the rate of insufficient biopsy. The sample size has been chosen on feasibility based on the number of patients investigated for Hirschsprung disease each year at Monash Children’s Hospital (20-30) with the aim of completing the trial within 18-24 months. Primary endpoints for the trial will be the effectiveness and the complications with each SRB forceps - Number of biopsies attempted at each episode - Number of inadequate specimens obtained - Number of biopsy episodes performed - Complications: o Bleeding requiring admission/blood transfusion o Rectal perforation o Pelvic abscess/sepsis