Portal de Periódicos da CAPES

929f Comparing standard colonoscopy with EndoRings™ colonoscopy: a randomized, multicenter tandem colonoscopy study – interim results of the CLEVER study

2014; Elsevier BV; Volume: 146; Issue: 5 Linguagem: Inglês

10.1016/s0016-5085(14)60570-9

1528-0012

Vincent K. Dik, Ian M. Gralnek, Ori Segol, Alain Suissa, Leon M.G. Moons, Sveta Domanov, Meytal Segev, Douglas K. Rex, Peter D. Siersema,

Colorectal Cancer Screening and Detection

Adenoma miss rates during colonoscopy have become widely acknowledged.This is mainly due to inadequate visualization of the proximal aspects of colonic folds and flexures.EndoR-ings™ (EndoAid, Caesarea, Israel) is a silicone rubber device that is fitted onto the distal end of the colonoscope.Its flexible circular wings engage and mechanically stretch colonic folds during withdrawal.Aims We compared adenoma miss rates (per lesion analysis) between standard colonoscopy (SC) and colonoscopy with EndoRings™ (EC).Secondary aims were to compare polyp miss rates, cecal intubation time, withdrawal time, total procedure time and adverse events.Methods In this multicenter tandem colonoscopy study, subjects referred for screening, surveillance or diagnostic colonoscopy were randomly assigned to undergo EC followed by SC or SC followed by EC.Both colonoscopies were performed on the same day by the same endoscopist.Polyps detected during the first procedure were immediately removed.Diminutive (1-2 mm), rectal polyps with hyperplastic appearance were not removed.The study sample size was calculated with a two-group chisquare test with 80% power and 0.05 two-sided significance level.Based on an expected adenoma miss rate of 35% with SC and 10% with EC, an expected mean number of adenomas per subject of 0.75 and a 10% drop-out rate, a total sample size of 126 subjects will be required.Results To date, 71 subjects have been enrolled.After excluding 5 subjects due protocol violations, 66 subjects (61% male, mean age 57.6 ± 9.6 years) remain for analysis.Indications for colonoscopy were screening n=19 (29%), surveillance n=19 (29%) and diagnostic evaluation n=28 (42%).There were 32 subjects randomly assigned to undergo EC first followed by SC and 34 subjects to undergo SC first followed by EC.In the study group, 29 adenomas were detected during first pass with EC and 5 additional adenomas during the second procedure with SC.In the control group, 13 adenomas were detected during the first pass colonoscopy with SC and 12 additional adenomas during the second procedure with EC.The adenoma miss rate (15%) in subjects undergoing EC first was statistically significantly (p<0.01)lower compared to subjects who underwent SC first (48%).Similar results were found for polyp miss rates, i.e. 12% for EC and 58% for SC (p<0.001).Mean cecal intubation times (9.6 min.vs. 8.1 min., p=0.17) and withdrawal times (7.2 min.vs. 6.8 min., p=0.14) were not significantly different between EC and SC.Mean total procedure time was longer (p<0.01) with EC (22.1 min.)compared to SC (18.0 min.)due to removal of more polyps.No adverse events occurred.Conclusion The interim results of this study (inclusion of all patients expected before DDW 2014) demonstrate that as compared to SC, colonoscopy with EndoRings™ has significantly lower adenoma and polyp miss rates.