3D printing and intelligent technology increase convenience, reliability, and patient acceptance of ostomy nursing: a randomized controlled trial

Traditional ostomy bags commonly cause skin allergy and inflammation around the stoma, as well as leakage. This study aimed to examine the effect of a 3D-printed ostomy bag with sensors and stimulators on stoma nursing. This is a randomized controlled trial. This trial involved 113 distinct individuals who undergo colorectal cancer surgery and intestinal obstruction surgery, with resulting stoma. The date of trial registration was January 17, 2019, and the date of first recruitment was May 1, 2019. Patients were randomized into two groups: intelligent 3D-printed ostomy bag (3D group, n = 57) and Coloplast one-piece pouching systems (control group, n = 56). The shape of ostomy and the surrounding skin of all the 57 patients of the 3D group was scanned by a handheld 3D scanner. Then, the ostomy bag chassis (also known as skin barrier) was 3D printed and an intelligent device adhered to the ostomy bag. The wearing time, leakage rate, the Discoloration, Erosion, and Tissue Overgrowth (DET) score, and the Acceptance of Illness Scale (AIS) were observed. In the 3D-printed bag group, the time to wear (0.7 +/- 0.4 m) was significantly shorter than that of the control group (9.1 +/- 3.5 m). The leakage rate of 3D-printed bag (1.75%) was significantly lower than that of the control group (16.1%). The DET score for the 3D-printed bag group was also lower than that of the control group, and the AIS score for the 3D-printed bag group was higher than that of the control group. The 3D-printed ostomy bags and the linked computer program can significantly reduce wearing time, leakage rate, and stoma complications. This may improve the quality of home ostomy care for patients and reduce the incidence of skin complications around the stoma.Registration number: ChiCTR1900020752.