Results of a Randomised, Multi-Centre, Single-Blind Trial to Compare the Efficacy, Acceptability and Safety of a New 2-Litre Gut Cleansing Solution Versus a Standard 4-Litre PEG+E Solution

*S1555 Results of a Randomised, Multi-Centre, Single-Blind Trial to Compare the Efficacy, Acceptability and Safety of a New 2-Litre Gut Cleansing Solution Versus a Standard 4-Litre PEG+E Solution Christian Ell, Hans-Juergen Gruss AIM:Todemonstrate that aneworal gut cleansing solutionNRL994 is as effectiveas the existing polyethylene glycol 3350 plus electrolytes (PEG+E) solution as a bowel preparation prior to colonoscopy. METHODS: The study was carried out as a randomised, single-blind, active-controlled, multi-centre study with two parallel treatment groups. Only patients (aged: 18-85 years) scheduled to undergo routine colonoscopy without history of colonic surgery, presence of colonic obstruction/ perforation of the colon, severe cardiovascular conditions and terminal kidney or liver diseases were eligible. Both gut lavage solutions were taken as half dose the eveningbefore followedbytheotherhalf onthemorningof thecolonoscopy.Primary efficacy criteria was the gut cleansing quality, as judged by a blinded expert panel on the basis of videotapes. Secondary endpoints were the degree of gut cleansing in predefined gut segments, overall gut cleansing, evaluation of taste, patient’s satisfaction and acceptability and a full safety assessment. RESULTS: A total of 359 patients (180 with NRL994 and 179 with PEG+E) in 12 centres received study medication. 9 patients withdrew during the study. 42 cases were major protocol violators, mainly related to the absence of a videotape recording. Therefore, 308 patients (153 with NRL994 and 155 with PEG+E) were analysed for the primary efficacy endpoint. The overall success rate was 88.9% in the NRL994 group and 94.8% in thePEG+Egroup.NRL994 is as effective as PEG+E.Themean scores of gut cleansingwere 2.5+/ 0.5 in theNRL994groupand2.5+/ 0.4 in thePEG+E group. Patients consistently preferredNRL994 overPEG+E, assessedby the degree of patient satisfaction, overall acceptability of the gut cleansing solution and taste assessment. Both treatments were well tolerated and had similar adverse event profileswith frequentmild treatment-relatedmalaise, nausea, unspecifiedabdominal pain and vomiting. No relevant shifts in the laboratory tests were observed. CONCLUSION: The study has shown that the new 2 litre NRL994 gut lavage solution proved to be as effective as the existing 4-litre PEG+E solution. Patients consistently preferred NRL994 to PEG+E. Both treatments proved to be safe and generally well tolerated. This new lower volume bowel cleansing solution provides abetterpatientacceptabilitywithout any lossof efficacyor enhanced safety concerns. Comparison of Endoscopic Experience Obtained in an American and a British Gastroenterology Training Program Sean Weaver, Sanjib Mohanty, David Fine, Paul Winwood, Kim Isaacs, Ian Grimm Introduction: Endoscopy represents a central part of gastroenterology training but very little is known about the experience gained in training. The recommendations for endoscopic experience by the ASGE, and the joint advisory group (JAG) for endoscopy in Britian, suggest a relatively low volume of experience to become competent. Three year American programs are shorter than British training which has a minimum of four dedicated years. However many British trainees do more and intercalate a higher research degree. There have been concerns that if the intensity and length of British training are shortened then endoscopic training will suffer. Methods: The records of endoscopic experience from 11 trainees completing the gastroenterology program at the University of North Carolina at Chapel Hill were compared with 9 trainees within one year of completion of training in the British region of Wessex. Results: American and British trainees significantly exceeded both British and American recommendations for experience in both upper and lower gastrointestinal endoscopy. British trainess carried out significantly more upper gastrointestinal endoscopy (mean 2429 vs 662 p<0.05; ASGE recommendation 130; JAG guideline 300) and tended to carry out more colonoscopy (mean 664 vs 483 ns; ASGE recommendation 140; JAG guideline 200). The recommendation of 200 ERCP procedures was only reached by some trainees in both America (3/11; mean 172) and Britain (7/8; mean 198). All procedures in America were supervised by a trainer. In Britain supervision was often indirect once competence was demonstrated. Conclusions: In both training programs trainees get extensive experience in both upper and lower gastrointestinal endoscopy. Obtaining appropriate experience in ERCP is not always achieved which has resulted in some programs training only some of its trainees. The reasons why British trainees gain more upper gastrointestinal experience are probably dependent on length of training (including 8/9 having a research degree), differences in endoscopic practice between the two countries, and time spent outside a tertiary referral teaching hospital environment. There is evidence that training in general endoscopy in Britain would be adequate if British training is shortened or made less intense.