A0617 - Compassionate Use of an Intermittent Colonic Exo-Peristaltis Device for a Handicapped Minor to Treat Chronic Constipation

Immaculada Herrero-Fresneda, PhD
MOWOOT, USMIMA S.L., Esplugues de Llobregat, Catalonia, Spain

Introduction: A nurse professionally dedicated to her daughter (S) used to give S manual colonic massage which usually provoked her tendinitis due to daily administration and force needed. The pediatric gastroenterologist (EJH; Child.Hosp.Colorado), at the request of the mother asked the FDA for the compassionate use permission of MOWOOT device. This medical device automatically gives an intermittent colonic exo-peristaltis (ICE) that has been demonstrated to be safe and effective in a previous clinical trial (doi:10.14309/ctg.0000000000000267).

Case Description/Methods: S. was a 12 year-old girl, with anatomic proportions of a 6yr (22kg), with Trisomy 21, severe autism, mixed receptive-expressive language disorder, moderate to severe vision impairment in both eyes, self-aggressive crises, and severe chronic constipation from NBD origin. Prior treatments for constipation included PEG laxatives, extra fluids, extra fiber, and enemas. S received nutrition via a G-tube but frequently pulled out the tube. S lacked intellectual capacity for behavioural modification programs. She was placed an additional J-tube for nutrition. The G-tube was maintained for medication. The next treatment option was a surgically placed cecostomy tube for ante-grade enemas. Due to S behavioural issues, an additional tube was not likely to be successful, and S was at high risk of infection. Here the compasionate use started.

For 45 days S. received 20min treatment daily. The mother registered in a bowel diary the number of bowel movements, fecal consistency, quantity of evacuated feces, and dose of laxative taken. Before and after the study the bowel function was assessed on a visual analogue scale (VAS, 0:No problems; to 10:A lot of problems to defecate). To use the ICE device, both G and J tubes had to be disconnected. The active pneumatic elements of the belt directly worked onto the occluded osteomas.

Discussion: Despite the challenges, the treatment worked well from and there was no adverse event reported. S enjoyed the treatment from the first day and reduced her self-aggressiveness. After 4 weeks of use, the bowel movements increased by 2/week, while the dose of laxatives decreased. The defecatory function ameliorated from 8.5 to 2.5 (VAS, d1 to d45). The improvement progressed over time. Three months later, the patient had gained 8 Kg weight and was notably calmer.

The safety, tolerability, and effectiveness of the ICE system was demonstrated. The patient’s and family’s whole quality of life was significantly increased.




Disclosures:


Immaculada Herrero-Fresneda, PhD. A0617 - Compassionate Use of an Intermittent Colonic Exo-Peristaltis Device for a Handicapped Minor to Treat Chronic Constipation, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.