A novel 1-L PEG + ascorbate versus high-volume PEG regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study

Published on Apr 30, 2021in Gastrointestinal Endoscopy6.89
· DOI :10.1016/J.GIE.2021.04.020
Alessandro Repici71
Estimated H-index: 71
(Humanitas University),
Cristiano Spada45
Estimated H-index: 45
(UCSC: Catholic University of the Sacred Heart)
+ 28 AuthorsCesare Hassan92
Estimated H-index: 92
Background and Aims An adequate bowel cleansing is critical to assure quality and safety of colonoscopy. A novel 1L-PEG plus ascorbate(PEG+ASC) regimen was previously validated against low-volume regimens, but it was never compared with high-volume regimens. Methods In a Phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4L PEG-based regimen in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by the local endoscopists and centralized reading, both blinded to the randomization arm. Primary endpoint was noninferiority of 1L PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate (ADR), tolerability and safety. Results A total of 388 patients (59.8 years) were randomized between January 2019 and October 2019: 195 to 1L PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L PEG+ASC was demonstrated for cleansing in both the whole colon (BBPS > 6: 97.9% vs 93%; RR, 1.03; 95% CI, 1.001-1.04; p-superiority=0.027) and in the right colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, 0.99-1.02; p noninferiority=0.013). Compliance was higher with 1L PEG+ASC than 4L-PEG (178/192, 92.7% vs 154/190 patients, 81.1%; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side-effects: 20.8% vs 25.8%; p=0.253). No difference in ADR (38.8% vs 43.0%) was found. Conclusion 1L PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing, as well as a higher patient compliance. No differences in tolerability and safety were detected.
📖 Papers frequently viewed together
31 Citations
7 Citations
40 Citations
#1Marco Spadaccini (Humanitas University)H-Index: 14
#2Leonardo Frazzoni (UNIBO: University of Bologna)H-Index: 21
Last. Cesare HassanH-Index: 17
view all 27 authors...
Abstract: Background & Aims Efficacy of bowel preparation is an important determinant of outcomes of colonoscopy. It is not clear whether approved low-volume polyethylene glycol (PEG) and non-PEG regimens are as effective as high-volume PEG regimens when taken in a split dose. Methods In a systematic review of multiple electronic databases through January 31, 2019 with a registered protocol (PROSPERO: CRD42019128067), we identified randomized controlled trials that compared low- vs high-volume b...
13 CitationsSource
#1Giuseppe Vanella (Sapienza University of Rome)H-Index: 8
#2Cesare HassanH-Index: 92
Last. Emilio Di Giulio (Sapienza University of Rome)H-Index: 21
view all 8 authors...
Background and aims A split-dose regimen for colonoscopy is recommended by international guidelines, but its adoption is still suboptimal. Our aim was to assess whether a Plan-Do-Study-Act approach (PDSA), a scientific method promoting quality improvement, would be able to improve adherence to a split-dose regimen, and to identify factors influencing its adoption. Methods This study consisted of three phases: Cycle 1: a cross-sectional assessment of split-dose adherence in consecutive outpatient...
#1Alessandro Repici (Humanitas University)H-Index: 71
#2Emmanuel CoronH-Index: 28
Last. Daniel C. Baumgart (U of A: University of Alberta)H-Index: 56
view all 9 authors...
Abstract Background & aims Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists. Methods Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-o...
2 CitationsSource
#1Cesare HassanH-Index: 92
#2James E. East (John Radcliffe Hospital)H-Index: 50
Last. Jean-Marc DumonceauH-Index: 75
view all 22 authors...
ESGE recommends a low fiber diet on the day preceding colonoscopy. Strong recommendation, moderate quality evidence. ESGE recommends the use of enhanced instructions for bowel preparation. Strong recommendation, moderate quality evidence. ESGE suggests adding oral simethicone to bowel preparation. Weak recommendation, moderate quality evidence. ESGE recommends split-dose bowel preparation for elective colonoscopy. Strong recommendation, high quality evidence. ESGE recommends, for patients underg...
65 CitationsSource
#1Alessandro RepiciH-Index: 71
#2Cesare HassanH-Index: 92
Last. Raf Bisschops (Katholieke Universiteit Leuven)H-Index: 47
view all 4 authors...
#1Douglas K. Rex (IU: Indiana University)H-Index: 116
8 CitationsSource
#1Stefan SchreiberH-Index: 186
#2Daniel C. Baumgart (U of A: University of Alberta)H-Index: 56
Last. Cesare HassanH-Index: 92
view all 8 authors...
Background Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing. Methods Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SP + MC. Cleansing was assessed on the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS) using central ...
30 CitationsSource
#1Raf Bisschops (Katholieke Universiteit Leuven)H-Index: 47
#2J Manning (Borders General Hospital)H-Index: 1
view all 5 authors...
Background Polyethylene glycol (PEG)-based bowel preparations are effective cleansers but many require high-volume intake. This phase 3, randomized, blinded, multicenter, parallel-group, central reader-assessed study assessed the 1 L PEG NER1006 bowel preparation vs. standard 2 L PEG with ascorbate (2LPEG). Methods Patients undergoing colonoscopy were randomized (1:1:1) to receive NER1006, as an evening/morning (N2D) or morning-only (N1D) regimen, or evening/morning 2LPEG. Cleansing was assessed...
33 CitationsSource
#1Michael DeMiccoH-Index: 1
#2Lucy ClaytonH-Index: 2
Last. Kenneth E. SmithH-Index: 1
view all 21 authors...
Background and Aims NER1006 is the first 32 fluid ounce (1 L) polyethylene glycol-based bowel preparation. This randomized, multicenter, colonoscopist/central reader-blinded phase 3 non-inferiority trial assessed the efficacy, safety, and tolerability of NER1006 versus trisulfate for bowel cleansing. Methods Patients undergoing colonoscopy were randomized (1:1) to receive NER1006 or trisulfate, using evening/morning split-dosing administration. Blinded central readers used the validated Harefiel...
34 CitationsSource
#1Joseph C. Anderson (Dartmouth College)H-Index: 34
#2John A. Baron (Dartmouth College)H-Index: 6
Last. Douglas J. Robertson (Dartmouth College)H-Index: 49
view all 14 authors...
Background & Aims Endoscopists do not routinely follow guidelines to survey individuals with low-risk adenomas (LRAs; 1–2 small tubular adenomas, Methods We collected data from 1560 individuals (45–75 years old) who participated in a prospective chemoprevention trial (of vitamin D and calcium) from 2004 through 2008. Participants in the trial had at least 1 adenoma, detected at their index colonoscopy, and were recommended to receive follow-up colonoscopy examinations at 3 or 5 years after adeno...
39 CitationsSource
Cited By0