Low-volume reduced bowel preparation regimen for CT colonography: a randomized noninferiority trial

Abstract

Purpose: To determine whether the quality of a low-volume reduced bowel preparation (LV-RBP) for CT Colonography (CTC) is noninferior to full-volume reduced bowel preparation (FV-RBP) regimen.

Methods: In this randomized 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 blinded readers who rated the quality of bowel preparation from 0 (best score) to 3 (worst score). The primary outcome was the noninferiority of LV-RBP to FV-RBP in the proportion of colonic segments scored 0 for cleansing quality, with noninferiority margin of 10%. Volume of residual fluids, colonic distension, lesions and polyps detection rates and patient tolerability were secondary outcomes.

Results: From March 2019 to January 2020, 110 participants (mean age 65 years ± 14 [standard deviation]; 74 women) were allocated to LV-RBP (n = 55) or FV-RBP (n = 55) arms. There were 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. 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 fluids and colonic distension were also noninferior 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 for CTC demonstrated noninferior quality of colon cleansing with improved gastrointestinal tolerability compared to FV-RBP regimen.

Keywords: Colonography; Colorectal Neoplasms; Computed Tomography; Feasibility Studies; Hypertonic Solutions; Laxatives.