Chen Liu, M.B.Ch.B. • Emma Ludlow, B.H.Sci. • Robert B. Davidson, B.E. John B. Davidson, Ph.D. • Kaitlyn S. Chu, B.E. (Hons.) • Gregory O’Grady, Ph.D. Ian P. Bissett, M.D
Background & aims: High output enterostomy is a common cause of intestinal failure. Chyme reinfusion is a potential solution but widespread use has been limited due to existing methods lacking purpose-built equipment, and low patient acceptance due to unpleasant workflows. The aim of this feasibility study was to assess user experience, device performance and clinical outcomes of a novel stoma-output reinfusion device in ileostomy patients.
Methods: Ethical approval was granted by the local ethics committee. The device is comprised of a custom enteral feeding tube inserted into the downstream ileostomy limb and connected to a compact centrifugal pump resting within the stoma appliance. To activate the pump, a hand-held driver unit is held adjacent but external to the stoma appliance, achieving magnetic coupling and facilitating bolus chyme reinfusion. Adult patients with a defunctioning ileostomy were eligible. Anastomotic leak from distal anastomoses were first excluded via radiologic examination. The primary outcomes were the trends in patient user-experience feedback scores over progressive device iterations. Secondary outcomes included safety, technical and clinical factors. Descriptive statistics were employed to summarize outcomes.
Results: Nineteen patients were recruited from April 2019-May 2020. A total of 549 patient-days of device use were captured. In the early study period, off-the-shelf gastrostomy feeding tubes were used but multiple tube-related problems instigated the development of a custom chyme-reinfusion tube. This led to an improvement in the median patient-reported ease of use and preference scores (from 4/10 to 2/10 (10 representing high difficulty) and from 3/10 to 7/10 (10 representing strongly preferring reinfusion over discarding chyme), respectively). Clinical benefits included reduction in net stoma losses per day, testing of bowel function and reduction/cessation of anti-diarrhoeal medications. Fourteen patients underwent reversal with three experiencing post-operative ileus. Seven minor and two serious device-related adverse events were recorded. Both serious adverse events led to design alterations to prevent future events.
Conclusion: A novel stoma-output reinfusion device was refined and found to be user-friendly, safe, effective and acceptable to ileostomates in the community. This device is a valuable addition to the management options for intestinal failure.