Carolina ColoWrap® in Colonoscopy Performance and Outcomes (C3PO) Study: Results From a Randomized, Blinded, Sham-Controlled Clinical Trial: 1487

Introduction: Looping is a common problem during colonoscopy that prolongs procedure time, causes patient discomfort, and increases procedural risk. An external abdominal binder device (ColoWrap) has been designed to apply pressure to the lower abdomen during colonoscopy to reduce looping. We aimed to determine the efficacy and safety of Colo Wrap with respect to insertion time and other procedural outcomes. Methods: At a single academic center, eligible patients undergoing colonoscopy between the ages of 40-80 were randomized to have either Colo Wrap or a sham device applied to the lower abdomen during the procedure. Colonoscopists and other procedure staff were blinded to study group. The primary outcome was cecal intubation time (CIT). Secondary outcomes included use of manual pressure and position change and adverse events. Groups were compared using t-tests and Chi-squared 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 age of participants was 60.5 years (SD 8.4), and 216 (62%) were women. Colonoscopy was incomplete in 3 patients in the sham group vs. 1 patient in the Colo Wrap group (p=0.32). In the intention-to-treat analysis, the mean CIT was similar for those in the sham and Colo Wrap groups (6.69 min vs. 6.67 min, p=0.98) (Table). Manual pressure and position change occurred more frequently in the sham arm compared to the Colo Wrap arm, but this was not statistically significant (45% vs. 37%, p=0.13, and 4% vs. 2%, p=0.36, respectively). In subgroup analyses, results were similar after stratification by age and gender. After stratifying by BMI, use of Colo Wrap was associated with significantly lower mean CIT in participants with BMI≥30 compared to the sham arm (4.69 min vs. 6.08 min, p=0.027). There was also a trend towards reduction in manual pressure and change of position in obese subjects. In a per protocol analysis, Colo Wrap was associated with significantly reduced mean CIT, and those requiring ancillary maneuvers. The number of adverse events did not differ between groups.Table 1: Results for primary and secondary outcomes, subgroups and per-protocol analysisConclusion: Use of an external abdominal binder device during colonoscopy did not improve CIT overall, but did reduce CIT for obese participants. There were not significant differences in use of ancillary maneuvers, except in the per-protocol analysis. Colo Wrap appears to be a safe device that may have utility in reducing looping in a subgroup of patients undergoing colonoscopy.