James P Hathorn, Mark A Dubinski, MD, Marybeth Spanarkel, MD. ColoWrap, LLC, Durham, NC; Carolina GI Associates, Henderson, NC; Regional Gastroenterology Associates, Durham, NC.
OBJECTIVE: Looping of the endoscope during colonoscopy is a primary cause of patient discomfort, increased procedure time, and cecal intubation failure. Despite numerous technological advances, successful cecal intubation often requires the application of manual abdominal pressure or repositioning of the patient. These maneuvers lack uniformity in application and are variably effective. Additionally, the performance of these maneuvers can place both patients and providers at risk of injury. A pilot study was conducted to assess whether the use of a purpose-designed lower abdominal binder may facilitate colonoscopy and reduce the need for ancillary maneuvers, ostensibly by reducing loop formation.
METHODS: This was a prospective cohort pilot study. An abdominal binder device (ColoWrap, LLC) was applied to the lower abdomen prior to sedation for the procedure. The comparison group included participants undergoing colonoscopy by the same endoscopist (MS) during the same time period without the device. Patients with incomplete colonoscopies due to poor-prep or secondary medical co-morbidities were excluded. The primary outcome was cecal intubation time. Secondary outcomes included whether abdominal pressure or patient repositioning was required during the procedure, and the observed frequency of prolonged insertion times (defined as greater than 10 min).
RESULTS: 233 participants (160 females, 73 males; mean age 59) were included; 73 participants had the colonoscopy binder applied, and 160 controls underwent colonoscopy without the device. Use of the colonoscopy binder was associated with a 20% reduction in mean cecal intubation time compared to the control arm (4.3 minutes vs. 5.3 minutes, difference of 1.1 minutes, p = 0.001). Additionally, use of the binder reduced the use of abdominal pressure by 91% (12.5% versus 62.5% of procedures, p <0.001) and patient repositioning by 93% (4.1% versus 26.9% of procedures, p <0.001). Lastly, while in the control arm there were 13 procedures with insertions times greater than 10 minutes, there were no observed instances of prolonged insertions when the device was applied.
CONCLUSION: Use of the ColoWrap® colonoscopy binder reduced insertion time and the frequency of prolonged insertions while also minimizing the need for abdominal pressure or patient repositioning during colonoscopy in this single-center nonrandomized pilot study. Additional, randomized studies are needed to determine if this simple, non-invasive device can improve colonoscopy for patients and providers alike, and to identify patient populations most likely to benefit from its use.
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