The Effect Of Provider Experience On Efficacy Of Colowrap (R) Use During Colonoscopy: Results From A Randomized-Controlled Trial

Introduction: Looping of the insertion tube is a technical challenge of colonoscopy that affects all endoscopists. ColoWrap is a single-use, non-invasive abdominal compression device designed to apply pressure on the abdomen during colonoscopy to combat looping. We aimed to analyze the effect of the operator's experience level on the efficacy of the ColoWrap device. Methods: A randomized, blinded, sham-controlled trial was performed at a single academic center. Eligible patients undergoing colonoscopy between the ages of 40-80 were randomized to have either ColoWrap or a sham device applied to the lower abdomen during the procedure. Endoscopists and other procedure staffwere blinded to group assignment. The primary comparison for this analysis was cecal intubation time (CIT), stratified by endoscopist experience [fellows, junior faculty ( < 10 years experience), senior faculty (≥10 years experience), and highest volume endoscopist], overall and within prespecified subgroups of age, BMI, and gender. Groups were compared using t-tests and chi-squared or Fisher's exact tests. Results: 350 patients were enrolled, 175 in each study arm. Study groups were similar with respect to age, sex, race, and BMI. The mean cecal intubation time (CIT) for all patients was similar in the ColoWrap and sham arms after stratification by endoscopist experience. There were no differences between treatment groups by endoscopist type after stratification by age and sex. However, in patients with BMI ≥30, mean CIT was significantly decreased for senior faculty in the ColoWrap vs. sham arms (4.1 vs. 5.7 min, p=0.03) (Table). Similarly, mean CIT was reduced in obese subjects for the highest-volume endoscopist using ColoWrap by nearly 3 minutes, but this did not reach statistical significance (p=0.09). Gastroenterology fellows had a lower mean CIT when using ColoWrap than in the sham group in the obese, but the numbers were small and this was not statistically significant (Figure). In obese patients, maximum CIT was also reduced with ColoWrap, particularly for senior faculty (18.5 vs. 6.7 minutes). In addition, for obese participants, there were also trends toward less manual pressure needed in the Colowrap vs. sham groups for all endoscopist types. Conclusion: ColoWrap reduces CIT for some colonoscopies, particularly in obese patients. This effect is observed even in highly experienced endoscopists. Notably, the benefit of ColoWrap in obese patients is not limited to less experienced endoscopists.Table 1Figure 1