Multicenter prospective feasibility study on compliance, safety, and acceptance of small bowel and colon capsule endoscopy in the out-of-clinic setting in Japan.

Abstract

Objectives: We aimed to determine the compliance, safety, and acceptance of colon capsule endoscopy (CCE) and small bowel capsule endoscopy (SBCE) in an out-of-clinic setting remotely supported by medical staff.

Methods: We enrolled 30 examinees (24 with CCE and six with SBCE) who had not undergone CE at six gastroenterological centers. All examinees were provided with instructions on equipment and bowel preparations.

Results: CCE was performed at home (n = 16) or at the workplace (n = 8). Compliance with data-recorder alerts was 100% for bowel preparation and 79% for equipment operation. Total capsule colonoscopy was achieved in 83.3%. The overall adequate endoscopic cleansing rate was 83.3%, and abnormalities, including colorectal polyps, were detected in 37.5%. CCE malfunction, such as the inability to automatically detect the small bowel mucosa occurred in one (4.2%). One experienced mild abdominal pain that required no treatment. Inquiries were present from half of the examinees. The proportions of examinees who desired and refused CCE at the next examination were 67% and 4%, respectively. SBCE was performed at home (n = 4) or at the workplace (n = 2). Compliance with the procedures was 100%. Whole small bowel images were recorded for all examinees. The overall adequate endoscopic clearness rate was 100%. One abnormality was detected. Inquiries were present from half of the examinees. There were no adverse events or malfunctions. The proportion of examinees who reported "quite easy" and "fairly easy" was 66%.

Conclusion: CCE and SBCE with all procedures in the out-of-clinic setting supported by remote consultations were feasible. A multicenter prospective study of the safety and acceptance of capsule endoscopy examinations at home (HomeCam-J study) (jRCTs042220163).