Author Block: S. Vicini1, D. M. Bellini1, N. Panvini1, M. Rengo2, I. Carbone2; 1Latina/IT, 2Rome/IT
Purpose or Learning Objective: To determine whether the quality of low-volume reduced bowel preparation (LV-RBP) for CT colonography (CTC) is non-inferior to full-volume reduced bowel preparation (FV-RBP) regimen.
Methods or Background: In this randomised controlled trial, consecutive participants referred for CTC were randomly assigned to receive LV-RBP (52.5 g of PMF104 in 500 mL of water) or FV-RBP (105 g of PMF104 in 1000 mL of water). Images were independently reviewed by five readers who rated the quality of bowel preparation from 0 (best score) to 3 (worst score). The primary outcome was the non-inferiority of LV-RBP to FV-RBP in the proportion of colonic segments scored 0 for cleansing quality, with a non-inferiority margin of 10%. The volume of residual fluids, colonic distension, lesions and polyps detection rates and patient tolerability were secondary outcomes.
Results or Findings: 110 participants (mean age 65 years±14 SD) were allocated to LV-RBP (n=55) or FV-RBP (n=55) arms. There was 92% segment scored 0 in colon cleansing quality in LV-RBP and 94% in FV-RBP for prone scans, and 94% vs 92% for supine scans. The risk difference was -2.1 (95% CI −5.9 to 1.7) and 1.5 (95%CI −2.4 to 5.4) for prone and supine positions, respectively. Residual fuids and colonic distension were also non-inferior in LV-RBP. LV-RBP was associated with a lower number of evacuations during preparation (7±5 vs 10±6, p=0.002).
Conclusion: The LV-RBP demonstrated the non-inferior quality of colon cleansing with improved gastrointestinal tolerability compared to the FV-RBP regimen.
Limitations: The number of participants enrolled was relatively small. Second, we were not able to evaluate CTC diagnostic accuracy for polyps detection. Third, the quality of colon cleansing was assessed exclusively by subjective analysis.
Ethics committee approval: Approval was obtained from the ethics committee of the Sapienza University of Rome.
Funding for this study: No funding was received for this study.