Clinical utility of purgative bowel preparation before capsule endoscopy: a multicenter, blinded, randomized controlled trial

Abstract

Optimal bowel preparation before capsule endoscopy (CE) is currently unknown. In this multicenter, blinded, randomized controlled trial, we assessed clinical effectiveness of 2 types of purgative regimen and a control arm of clear fluid only. Patients with suspected small intestinal bleeding were randomized into 3 arms: arm A, clear fluids only for 18 hours before CE and simethicone 200 mg in 150 mL water immediately before CE; arm B, same as A+ 2 L of polyethylene glycol (PEG) 12 hours before CE; and arm C, same as A+ 1 L PEG+ sodium ascorbate 3 hours before CE. To assess diagnostic yield, lesions were classified either as highly relevant (P2) or less relevant (P0 or P1) lesions. Small-bowel visualization quality (SBVQ) was assessed using the Brotz score. Patient tolerability was assessed using the visual analog scale (0-10, with lower scores indicating better tolerability). Two hundred twenty-nine patients completed the study. The mean age was 58.7 years (95% confidence interval, 29.3-87.9), and 47.2% were men. There was no significant difference in diagnosis of P2 lesions in arms A, B, and C (48.7%, 48.0%, and 45.9%, respectively; P= .94). Overall SBVQ and distal SBVQ were similar across the 3 arms (P= .94 and P= .68, respectively). Patients reported better tolerability in arm A (mean score, 1.5) compared with arms B and C (mean score, 3.5 and 2.6, respectively; P< .001). The use of a purgative bowel preparation before CE does not improve diagnostic yield or small-bowel visualization and is associated with lower patient tolerance. (Clinical trial registration number: ACTRN 12614000883617.).