Tu1061 SAME-DAY SINGLE-DOSE OF 2 LITER POLYETHYLENE GLYCOL IS NOT INFERIOR TO THE STANDARD BOWEL PREPARATIOIN IN AVERAGED-RISK PATIENTS: A RANDOMIZED,CONTROLLED TRIAL

Abstract

Split dose of 4 Liter (L) polyethylene glycol (PEG) is currently the standard regimen for bowel preparation (BP). However, it may be unnecessary for patients without high risks (e.g. old age, constipation and diabetes etc.) for inadequate bowel preparation. The study aimed to compare the efficacies of bowel cleansing between average-risk patients receiving same-day, single-dose of low-volume (SSL) PEG versus the standard regimen. This prospective, randomized, observer-blinded, non-inferiority study enrolled average-risk patients in three centers. Patients undergoing colonoscopy were randomized (1:1) to the SSL or standard group for BP. The primary outcome was adequate bowel preparation, defined by Boston Bowel Preparation Score (BBPS) ≥6 and each segmental score ≥2. Secondary outcomes included adverse events, cecal intubation rate and patient willingness to repeat BP etc. Among 2532 patients eligible for the study, 940 (37.1%) were at average-risk and 792 (31.3%) at high-risk for inadequate BP. The average-risk patients were randomly allocated to the SSL (n=470) or standard group (n=470). The baseline characteristics between the two groups were similar. Intention-to-treat analysis showed that the adequate rates of bowel preparation were 88.1% in the SSL group and 87.0% in the standard group (RR 1.10, 95%CI: 0.75-1.63, p=0.621).The overall BBPS was 7.3 ± 1.2 and 7.3 ± 1.3 respectively (p=0.948). No significant differences were found between the two groups with regards to the right, transverse and left segmental BBPS (all p>0.05). However, in terms of adverse events, patients in the SSL group reported less nausea (19.6% vs. 29.9%), vomiting (5.3% vs. 11.4%) and abdominal discomfort (2.2% vs. 6.0%) compared with those in the standard group. More patients in the SSL group were willing to repeat bowel preparation (94.0% vs. 89.5%，p=0.015). For average-risk patients, the SSL regime was not inferior to the split-dose of 4L PEG for the adequacy of BP. SSL regime was accompanied with less adverse events. This simplified regime can be suggested as an alternative preparation method for “easy-to prepare” population.Tabled 1Outcomes of bowel preparation and precedure-associated parametersSSL group (n=470)Standard group (n=470)p valueAdequate bowel preparation, n (%)414/470 (88.1%)409/470 (87.0%)0.621Adequate bowel preparation in segmental colon, n (%)Right417/446 (93.5%)411/440 (93.4%)0.957Transverse441/447 (98.7%)433/442 (98.0%)0.422Left437/447 (97.8%)434/445 (97.5%)0.817BBPS, mean (SD)7.3 ± 1.27.3 ± 1.30.948Incorrect diet restriction, n(%)35/449 (7.8%)48/448 (10.7%)0.134Preparation-to-colonoscopy interval ≥8 h, n (%)2/449 (0.4%)6/448 (1.3%)0.177Amount of solution actually taken< 80%, n (%)15/449 (3.3%)33/448 (7.4%)0.007Adverse events, n (%)101/449 (22.5%)189/448 (42.2%)<0.001Willingness to repeat BP, n (%)422/449 (94.0%)401/448 (89.5%)0.015Cecal insertion time (min), mean (SD)6.7 ± 4.76.4 ± 4.00.250Withdrawal time (min), mean (SD)9.0 ± 0.99.0 ± 1.00.456PDR, n (%)208/470 (44.3%)195/470 (41.5%)0.392 Open table in a new tab