Effectiveness of 1-L polyethylene glycol plus ascorbate versus 4-L polyethylene glycol for colonoscopy cleansing in split-dose: a multicentre, randomized, clinical trial (OVER2019)

Aims Adequate bowel cleansing is essential for a HQ colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) solution has been recently introduced. Nevertheless, the effectiveness of 1L-PEG+ASC over high-volume bowel preparations in IPs and OPs is still unclear.

Methods In a single-blinded phase-IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen in 10 Italian centers. Preparation was assessed with the BBPS by local blinded colonoscopists. The primary endpoint was noninferiority of 1L-PEG+ASC in CS. Secondary endpoints were EC, HQC-RC, PDR, ADR, patient compliance and safety ([Table 1]).

Table 1  Patient characteristics in the full analysis set (n = 446).

Results 478 pts were randomized: 242 to 4L-PEG and 236 to 1L-PEG+ASC.The 1L-PEG+ASC showed higher cleansing success rate (98.4% vs 96.0%;[RR], 2.207; 95% [CI], 1.207-4.033; p=.009), excellent cleansing (39.1% vs 27.7%; RR, 1.675; 95% [CI], 1.118-2.510; p=.012) and HQC-RC (52.3% vs 38.5%; RR, 1.750; 95% [CI], 1.194-2.564; p=.004).No differences in PDR (34.1% vs 32.9%, p=.787), ADR (25.5% vs 23.5%, p=.632) were found; also in subgroup analysis (OPs vs IPs), the 1L-PEG+ASC showed higher BBPS (7.8 ± 1.4 vs 7.4 ± 1.7; p=.035), CS (96.3% vs 88.6%; p=.018) and HQC-RC (62.2% vs 46.3%; p=.010)in OPs. Compliance and safety were comparable between the two arms. No serious AEs or deaths occurred ([Table 2]).

Table 2  Bowel cleansing outcomes

Conclusions The 1L-PEG+ASC showed higher effectiveness compared with 4L-PEG in achieving adequate CS, with similar compliance, tolerability and safety both in OPs and IPs.

Publikationsverlauf

Artikel online veröffentlicht:
14. April 2023