Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions.

BACKGROUND: Adequate bowel cleansing is essential for a high-quality, effective, and safe colonoscopy. OBJECTIVES: To evaluate the degree of colon cleansing comparing split-dosage versus non-split-dosage intake of two different polyethylene glycol (PEG) volumes (low-volume PEG + ascorbic acid vs standard-volume PEG-electrolyte solution) and to identify predictors of poor bowel cleansing. DESIGN: Single-blind, active control, randomized study. SETTING: Tertiary-care institutions in Italy. PATIENTS: This study involved adult patients undergoing elective colonoscopy. INTERVENTION: Colonoscopy with different bowel preparation methods. MAIN OUTCOME MEASUREMENTS: Degree of bowel cleansing. RESULTS: We randomized 895 patients, and 868 patients were finally included in intention-to-treat (ITT) analysis. Overall compliance was excellent (97%) for both preparation methods. No difference in tolerability was recorded. Palatability was superior with low volume compared with high volume (acceptable or good 58% vs 51%, respectively, P < .005), independently of intake schedule. PEG plus ascorbic acid produced the same degree of cleansing as standard-volume PEG-electrolyte solution (77% vs 73.4%, respectively, within the split-dosage group and 41.7% vs 44.3%, respectively, within the non-split-dosage group). Independently of PEG volumes, the split-dosage regimen produced markedly superior cleansing results over the same-day method (good/excellent 327/435, 75.2% vs 186/433, 43.0%, P = .00001). Maximum cleansing was observed in colonoscopies performed within 8 hours from the last fluid intake versus over 8 hours from the last fluid intake (P < .001). The degree of bowel cleansing affected both cecal intubation (failed intubation 11.7% with fair/poor preparation vs 1.2% with good/excellent preparation, P = .00001) and polyp detection rates (12.2% with fair/poor vs 24.6% with good/excellent preparation, P = .001). Aborted procedures were significantly more frequent in the non-split-dosage arm (21.2% vs 6.9%, odds ratio [OR] 3.60 [2.29-5.77], P < .0001). Independent predictors of poor bowel cleansing were male sex (OR 1.45 [1.08-1.96], P = .014) and a non-split-dosage bowel preparation schedule (OR 2.08 [1.89-2.37], P = .0001). CONCLUSION: Low-volume PEG plus ascorbic acid is as effective as high-volume PEG-electrolyte solution but has superior palatability. A split-dosage schedule is the most effective bowel cleansing method. Colonoscopy should be performed within 8 hours of the last fluid intake.

Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED Score and Prospective Comparison with the Rockall Score.

OBJECTIVES: We sought (i) to validate a new prediction rule of mortality (Progetto Nazionale Emorragia Digestiva (PNED) score) on an independent population with non-variceal upper gastrointestinal bleeding (UGIB) and (ii) to compare the accuracy of the Italian PNED score vs. the Rockall score in predicting the risk of death. METHODS: We conducted prospective validation of analysis of consecutive patients with UGIB at 21 hospitals from 2007 to 2008. Outcome measure was 30-day mortality. All the variables used to calculate the Rockall score as well as those identified in the Italian predictive model were considered. Calibration of the model was tested using the chi2 goodness-of-fit and performance characteristics with receiver operating characteristic (ROC) analysis. The area under the ROC curve (AUC) was used to quantify the diagnostic accuracy of the two predictive models. RESULTS: Over a 16-month period, data on 1,360 patients were entered in a national database and analyzed. Peptic ulcer bleeding was recorded in 60.7% of cases. One or more comorbidities were present in 66% of patients. Endoscopic treatment was delivered in all high-risk patients followed by high-dose intravenous proton pump inhibitor in 95% of them. Sixty-six patients died (mortality 4.85%; 3.54-5.75). The PNED score showed a high discriminant capability and was significantly superior to the Rockall score in predicting the risk of death (AUC 0.81 (0.72-0.90) vs. 0.66 (0.60-0.72), P<0.000). Positive likelihood ratio for mortality in patients with a PNED risk score >8 was 16.05. CONCLUSIONS: The Italian 10-point score for the prediction of death was successfully validated in this independent population of patients with non-variceal gastrointestinal bleeding. The PNED score is accurate and superior to the Rockall score. Further external validation at the international level is needed.

Identification of a lower grade muconodular subtype of gastric mucinous cancer.

Until now, survival analysis of gastric mucinous cancers showed either no difference or an even worse prognosis than stage-adjusted non-mucinous tumours. In the pancreas and breast, mucinous cancers showing well-demarcated mucin deposits (muconodular pattern), expansile growth and predominance of MUC2 mucin are known to have a more favourable prognosis. In this study, an attempt was made to separate, among 41 gastric mucinous cancers, a subgroup of tumours with muconodular expansile pattern, possibly predictive of a more favourable outcome. A group of 15 tumours was identified, which were characterised by overwhelming (80-100%) mucinous component, predominance of mucus over tumour cells inside muconodules, moderately aggressive growth of their epithelial component (reduced proliferative rate, moderate anaplasia, lack of angioinvasion and limited lymphoinvasion) and dominant expression of intestinal goblet cell markers, with special reference to MUC2 mucin. Univariate and multivariate survival analysis showed a significantly improved outcome of these lower grade muconodular tumours compared with the remaining mucinous cancers as well as with non-mucinous cancers of cohesive, diffuse (signet-ring cell included) and undifferentiated high-grade types.