Preparation Regimens to Improve Capsule Endoscopy visualization and diagnostic yield (PrepRICE); a multicentric randomized trial.

ABSTRACT

BACKGROUND AND AIMS: Current guidelines recommend bowel preparation before small-bowel capsule endoscopy (SBCE). However, the optimal protocol is yet to be defined. To determine the best timing for preparation in SBCE, we compared small-bowel visualization quality (SBVQ), diagnostic yield (DY), and patient-reported outcomes across four purgative regimens. METHODS: In this prospective, randomized (1111), multicentric study, patients with suspected small bowel bleeding were randomized into four arms G1 (1L of polyethylene-glycol + ascorbic acid [Moviprep®] the night before SBCE), G2 (1L in the morning, up to 2 hours before SBCE), G3 (0.5L up to 2 hours before + 0.5L after the capsule reached the duodenum), and G4 (1L after reaching the duodenum). To assess DY, lesions were categorized as having high (P2) or low (P0 or P1) bleeding potential. Small-bowel visualization quality (SBVQ) was assessed using the Brotz score. Transit times (TT) were measured, and patient tolerability was scored from 0 to 5 with higher scores indicating better tolerability. RESULTS: A total of 387 patients were included; 59% female with a median age of 73 years (IQR 23). The exam completion rate was lower in G1 (90%, p<0.001). Small bowel TT was shorter for patients receiving purgative during SBCE (G3 and G4, p=0.001). SBVQ was better in patients receiving purgative after reaching the SB (p<0.001) median of 7 for G1, 8 for G2, and 9 for G3 and G4. The overall DY of patients receiving intra-procedure purgatives (G3 + G4) was superior (42.7 vs 31.3%, p=0.02); significant differences were found in the second and third terciles. Likewise, G3 and G4 had higher angioectasia detection (p=0.04). Patients' satisfaction was significantly superior for G4 (median 4 points, IQR 1). CONCLUSIONS: The group that received the bowel preparation the night before SBCE had poorer outcomes. Intra-procedure purgative regimens reduced SBTT, enhanced visualization, improved DY, and increased angioectasia detection. G4 was the best-tolerated regimen.