Sedation does not increase adenoma or polyp detection, although it leads to an increase in CIR in men and women. This effect is more pronounced in women, yet CIR of men remains higher compared with women. Quality indicators are mainly influenced by the patient's age, sex, and the endoscopists' individual performance, rather than the endoscopists' subspeciality or procedural experience.
Background and study aims
Quality of inspection during colonoscopy is strictly related to the level of cleansing. High-volume (PEG-based) solutions are highly effective and safe, but their high volume affects tolerability and compliance. The aim of this study was to compare a new low-volume PEG with citrate and simethicone solution (PMF 104,Clensia) with a low-volume PEG with ascorbic acid solution (PEG-ASC; Moviprep).
Patients and methods
This was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where patients were randomized between PMF 104 and PEG-ASC. In both groups, patients were instructed to take a full-dose regimen the evening before if colonoscopy was scheduled before 11 am to 12 pm, or to take a split regimen if colonoscopy was scheduled after 11 am to 12 pm. The primary end-point was an equivalence between PMF104 and PEG-ASC in the rate of adequate level of cleansing (Ottawa scale ≤ 6), with safety, mucosal visibility, tolerability, acceptance and compliance being also assessed.
Results
Of the 403 enrolled, 367 patients (Mean age [SD]: 55.6 (14.4) years; male:166 [45.2 %]) were included in the per protocol (PP) analysis: 184 being randomized in the PMF 104 group and 183 in the PEG-ASC group. Successful bowel cleansing was 78.3 % and 74.3 % in PMF104 and in PEG-ASC, respectively (
P
= 0.37). Both preparations were equally safe (mild adverse events were observed in 9.2 % and 9.3 % of patients in the PMF104 and in the PEG-ASC group, respectively) and acceptable (no or mild distress during the intake in 81.4 % and 80.8 % in the PMF104 in the PEG-ASC, respectively [
P
= 0.74]).
Conclusion
The new low-volume product Clensia is equivalent to the reference low-volume PEG-ASC in terms of bowel cleansing, safety and acceptance.
Background: Clear evidence on the benefit-harm balance and cost effectiveness of population-based screening for colorectal cancer (CRC) is missing. We aim to systematically evaluate the long-term effectiveness, harms and cost effectiveness of different organized CRC screening strategies in Austria. Methods: A decision-analytic cohort simulation model for colorectal adenoma and cancer with a lifelong time horizon was developed, calibrated to the Austrian epidemiological setting and validated against observed data. We compared four strategies: 1) No Screening, 2) FIT: annual immunochemical fecal occult blood test age 40-75 years, 3) gFOBT: annual guaiac-based fecal occult blood test age 40-75 years, and 4) COL: 10-yearly colonoscopy age 50-70 years. Predicted outcomes included: benefits expressed as life-years gained [LYG], CRC-related deaths avoided and CRC cases avoided; harms as additional complications due to colonoscopy (physical harm) and positive test results (psychological harm); and lifetime costs. Tradeoffs were expressed as incremental harm-benefit ratios (IHBR, incremental positive test results per LYG) and incremental cost-effectiveness ratios [ICER]. The perspective of the Austrian public health care system was adopted. Comprehensive sensitivity analyses were performed to assess uncertainty. Results: The most effective strategies were FIT and COL. gFOBT was less effective and more costly than FIT. Moving from COL to FIT results in an incremental unintended psychological harm of 16 additional positive test results to gain one lifeyear. COL was cost saving compared to No Screening. Moving from COL to FIT has an ICER of 15,000 EUR per LYG. Conclusions: Organized CRC-screening with annual FIT or 10-yearly colonoscopy is most effective. The choice between these two options depends on the individual preferences and benefit-harm tradeoffs of screening candidates.
SUMMARYThe effect of prophylactic treatment of oesophageal varices by endoscopic injection sclerotherapy before the first episode of variceal haemorrhage was studied in patients with cirrhosis in a prospective, randomised and controlled multicentre trial. From February 1984 to March 1987 patients with liver cirrhosis and large varices (stage III-IV according to Paquet) were treated and followed up. The sample comprised 87 patients: 45 in the prophylactic treatment and 42 in the control group. After excluding drop outs, 41 patients were treated in each group. Twenty nine per cent of patients in the sclerotherapy group and 34% in the control group had a variceal haemorrhage during the period of observation. There was no significant difference in the distributions of the bleeding free intervals between the sclerotherapy and the control groups. During the follow up period 24% of patients in the sclerotherapy group and 46% in the control group died. The distribution of survival times indicates a tendency towards longer survival of patients with prophylactic sclerotherapy, particularly in those with alcoholic cirrhosis.Severe haemorrhages from oesophageal varices belong to the most serious complications in patients with liver cirrhosis and portal hypertension. About 30 to 70% of patients with liver cirrhosis develop oesophageal varices' and some 20-40% of these will eventually bleed.2 The mortality of the first haemorrhage has been reported to be between 30 and 80% .3 Although many studies from all over the world show that sclerotherapy during the acute bleeding phase will efficiently stop variceal bleeding-9 and repeated sclerotherapy after terminating the initial bleeding episode can increase the longterm survival of such patients,"' the first massive variceal haemorrhage is nevertheless fatal for many patients. It therefore
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