Erratum: Cold snare polypectomy of colorectal polyps ≤ 10 mm on clopidogrel: Australian and New Zealand randomized controlled trial.

[This corrects the article DOI: 10.1055/a-1813-1019.].

Split-dose 1 L polyethylene glycol (PEG) with ascorbate is non-inferior to split-dose PEG with sodium picosulfate and magnesium citrate with similar tolerability: a randomized study.

BACKGROUND AND AIM: Post-marketing studies comparing low-volume polyethylene glycol (PEG)-based regimens are limited. This randomized study aimed to compare the efficacy and tolerability of a novel 1-L low-volume PEG-based preparation: 1 L PEG+Asc (PEG3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride) with PEG+SPMC (PEG3350, sodium chloride, potassium chloride and sodium sulfate, sodium picosulfate, magnesium oxide, citric acid, and aspartame), prior to routine colonoscopy at an Australian tertiary referral center. METHODS: Outpatients undergoing colonoscopy were randomized to receive either split-dose 1 L PEG+Asc or split-dose PEG+SPMC. Bowel preparation quality using the Boston Bowel Preparation Scale (BPPS), modified Aronchick scores, procedure time, cecal intubation, and adenoma detection rates were recorded. Patient compliance and tolerability were captured using a standardized questionnaire. RESULTS: A total of 173 patients were randomized, of whom 164 completed the study and were allocated to 1 L PEG+Asc (n = 82) or PEG+SPMC (n = 82). Non-inferiority of 1 L PEG+Asc was demonstrated with 89% achieving successful preparation (total BPPS ≥6 and each sub-score ≥2) compared with 85.4% in the PEG+SPMC group, resulting in an estimated difference of 3.7% (95% CI -6.6% to 13.9%). The median BBPS was non-inferior in all colonic segments with 1 L PEG+Asc (BBPS 3 [interquartile range 2-3]) vs PEG+SPMC (BBPS 2 [interquartile range 2-3]). More 1 L PEG+Asc patients reported moderate to severe nausea (P = 0.028), but overall tolerability was similar. CONCLUSIONS: The quality of bowel preparation achieved with 1 L PEG+Asc is non-inferior to that with PEG+SPMC, with similar tolerability outcomes. Further studies are required in patients at risk of suboptimal bowel preparation.

Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial.

Concurrent cardiovascular disease and antiplatelet use (clopidogrel, prasugrel and ticagrelor) use poses a significant peri-endoscopic management challenge with a paucity of high-quality evidence available. Antiplatelet temporary interruption places patients at risk of serious cardiovascular thrombotic events. Continuing these agents potentially increases the risk of procedure related bleeding however this risk could be sufficiently mitigated by cold snare polypectomy and endoscopic clipping to manage intraprocedural bleeding, making routine colonoscopy on continued antiplatelet agents safe. The EPOC trial will examine whether continuation of antiplatelet therapy (clopidogrel, prasugrel or ticagrelor) as single or dual therapy with aspirin, is inferior or superior to temporary interruption of antiplatelet therapy, current standard of care, with regard to the use of endoscopic rescue clips or clinically significant post-polypectomy bleeding after cold snare polypectomy of polyps ≤10 mm. EPOC is a parallel group, proceduralist-blinded randomized controlled trial comparing recruiting patients on antiplatelet therapy undergoing elective colonoscopy. This trial is underway throughout Australia and New Zealand with a view to expanding to additional sites. 496 subjects in each arm are required for this study. EPOC is the first randomised controlled trial comparing temporary interruption with continuation of antiplatelet therapy in patients undergoing elective colonoscopy.

Augmentation with pre-emptive macrogol-based osmotic laxative does not significantly improve standard bowel preparation in unselected patients: A randomized trial.

BACKGROUND AND AIM: The addition of a laxative prior to a standard bowel preparation (BP) has shown variable results in efficacy, safety, and tolerability of the BP. This study compared the efficacy and tolerability of a macrogol-augmented BP (M-BP) with standard BP for routine colonoscopy in unselected patients. METHODS: Adults undergoing outpatient colonoscopy were randomized to either M-BP (one sachet of macrogol-based osmotic laxative (MBOL) twice daily for eight doses prior to standard preparation) or BP (split-dose of polyethylene glycol and sodium picosulfate). Bowel cleansing was assessed using the Ottawa BP scale. Risk factors for poor BP, patient satisfaction, and tolerance were recorded. RESULTS: This randomized trial was stopped due to futility after 14 months; at that point, 92 subjects were randomized to the study arm and 102 to the control arm. M-BP had a success rate of 71.7% (95% CI: 58.5-82.7%), while the BP had a success rate of 67.7% (95% CI: 54.9-78.8%), with a Pearson χ 2 test P-value of 0.639, which exceeded the cut-off for futility (0.313). In subgroup analyses, there were statistically significant decreases in the rates of successful BP in patients taking regular opioids and regular laxatives. Both preparations were well tolerated, with no difference between groups (BP - 5.3% and M-BP - 6.6% P = 0.66). CONCLUSION: The addition of MBOL prior to a standard BP in unselected subjects does not significantly improve bowel cleanliness at routine colonoscopy. The role of this laxative in patients at high risk of poor preparation warrants further investigation.

A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps.

BACKGROUND AND STUDY AIMS: The evidence for efficacy and safety of cold snare polypectomy is limited. The aim of this study was to assess the completeness of resection and safety of cold snare polypectomy, using either traditional or dedicated cold snares. PATIENTS AND METHODS: This was a prospective, non-randomized study performed at a single tertiary hospital. Adult patients with at least one colorectal polyp (size ≤ 10 mm) removed by cold snare were included. In the first phase, all patients had polyps removed by traditional snare without diathermy. In the second phase, all patients had polyps removed by dedicated cold snare. Complete endoscopic resection was determined from histological examination of quadrantic polypectomy margin biopsies. Immediate or delayed bleeding within 2 weeks was recorded. RESULTS: In total, 181 patients with 299 eligible polyps (n = 93 (173 polyps) traditional snare group, n = 88 (126 polyps) dedicated cold snare group) were included. Patient demographics and procedure indications were similar between groups. Mean polyp size was 6 mm in both groups ( P  = 0.25). Complete polyp resection was 165 /173 (95.4 %; 95 %CI 90.5 - 97.6 %) in the traditional snare group and 124/126 (98.4 %; 95 %CI 93.7 - 99.6 %) in the dedicated cold snare group ( P  = 0.16). Serrated polyps, compared with adenomatous polyps, had a higher rate of incomplete resection (7 % vs. 2 %, P  = 0.03). There was no statistically significant difference in the rate of immediate bleeding (3 % vs. 1 %, P  = 0.41) and there were no delayed hemorrhages or perforations. CONCLUSIONS: Cold snare polypectomy is effective and safe for the complete endoscopic resection of small (≤ 10 mm) colorectal polyps with either traditional or dedicated cold snares.

White Diet with split-dose Picosalax is preferred, better tolerated, and non-inferior to day-before clear fluids with polyethylene glycol plus sodium picosulfate-magnesium citrate for morning colonoscopy: A randomized, non-inferiority trial.

BACKGROUND AND AIM: Bowel preparations with polyethylene glycol (PEG) and clear fluids are often poorly tolerated. We compared an innovative low-residue White Diet and low-volume, split-dose Picosalax with the standard preparation at our institution of day-before clear fluids and combination PEG plus sodium picosulfate/magnesium citrate (SPMC). METHODS: Adults undergoing morning colonoscopy were randomized to either the White Diet and split-dose, two sachets of Picosalax (WD/PICO) or day-before clear fluids and 1-L PEG plus two sachets of SPMC (CF/PEG + SPMC). The primary endpoint was successful bowel preparation defined by an Ottawa bowel preparation score ≤ 6. An intention-to-treat analysis with a predefined non-inferiority margin of 15% was used to compare efficacy. RESULTS: A total of 250 patients were randomized (125 WD/PICO and 125 CF/PEG + SPMC). WD/PICO was non-inferior to CF/PEG + SPMC for successful bowel preparation by intention-to-treat analysis (58% WD/PICO vs 62% CF/PEG + SPMC, 95%CI: -14.2 to 6.2%) and per-protocol analysis (64% WD/PICO vs 65% CF/PEG + SPMC, 95%CI: -11.3 to 9.4%). Patients in the WD/PICO group reported greater satisfaction with the diet (P < 0.001), greater ease of following the diet (P < 0.001), and improved experience compared with prior colonoscopy (P < 0.0001), less bloating (P = 0.02), less weakness (P = 0.046), less hunger (P < 0.0001), and less interference with daily activities (P = 0.001). Procedure/withdrawal times and adenoma detection rates were similar between groups. CONCLUSION: Bowel preparation with the White Diet and low-volume, split-dose Picosalax was preferred and better tolerated without detriment to bowel preparation success compared with clear fluids and combination PEG plus SPMC for morning colonoscopy.

Randomized pilot evaluation of the supportive care intervention "CONNECT" for people following surgery for colorectal cancer.

BACKGROUND: Improvements can be made in the quality of cancer care if supportive care needs are addressed; however, there are few trials of supportive care interventions to guide policy and practice. OBJECTIVE: This study aimed to determine the effectiveness of a nurse-delivered telephone supportive intervention (the "CONNECT" intervention). DESIGN: This study was a pilot randomized controlled trial. Intervention group patients received 5 calls from a specialist colorectal nurse in the 6 months after hospital discharge. Each call was standardized, comprising the assessment of unmet need and the provision of information and emotional support. CONNECT was in addition to standard clinical follow-up. Patients allocated to the control group received standard follow-up only. SETTING: This study took place at the Royal Prince Alfred Hospital, Sydney, Australia. PARTICIPANTS: Patients (n = 75) were included who had been surgically treated for colorectal cancer (any stage). MAIN OUTCOME MEASURES: The main outcome measures were the unmet supportive care needs, health service utilization, and quality of life at 1, 3, and 6 months postdischarge. RESULTS: Of 87 eligible patients, 75 consented (86% consent rate). Thirty-nine patients were randomly assigned to CONNECT and 36 to usual care. At 6 months, there was a clinically relevant, but nonsignificant reduction in presentations to emergency departments (21% vs 33%; χ1 = 1.41, P = .23) and readmission to the hospital (37% vs 47%; χ1 = 0.82, P = .37) among intervention compared with control group participants. Nonsignificant differences between groups were found for all unmet supportive care need and quality-of-life scores, change scores, and trends. However, at 6 months, total quality-of-life scores were higher for intervention group patients than controls (106.0 vs 98.6). This difference (7.4) was clinically relevant. Improvements in total quality-of-life change scores demonstrated that at 6 months, improvements were more than twice as large and clinically significant in the intervention compared with the control group. CONCLUSIONS: CONNECT has shown promising indications on health system and patient outcomes that warrant a larger study to further investigate the potential of this intervention.