Disposable plastic liners for a colostomy appliance: a controlled trial and follow-up survey of convenience, satisfaction, and costs.
PURPOSE: The effectiveness of a disposable liner designed for a 2-piece colostomy appliance pouch was evaluated. DESIGN: Randomized, crossover trial with follow-up surveys. SETTING AND SUBJECTS: Nineteen participants were recruited from the Mayo Clinic in Scottsdale, Arizona, and the surrounding community. INSTRUMENTS: A Daily Colostomy Care Evaluation Record and tally sheet of times for ostomy care were designed by the authors. METHODS: Participants, acting as their own controls, were randomly assigned to use either an unlined or a lined appliance for 9 days. On day 10, participants switched to the opposite regimen, which was maintained through day 18. They recorded the time required for daily colostomy care and perceptions of the lined and unlined appliances. The volume of ostomy supplies and cost were recorded at baseline, 1, 3, and 5 to 9 months after the initial trial. RESULTS: Odor, bother, perceived severity of leakage, and partner acceptance were better with unlined than lined appliances. Half of the participants were using a liner > or =75% of the time 3 months after the trial. There was no difference in cost when lined versus unlined ostomy systems were compared. Participants who chose to use the liners indicated high satisfaction. Problems noted included an inadequate seal with the liner (58%), inadequate liner size (16%), retention of flatus by the liner (11%), and difficulty removing the full liner (11%). CONCLUSIONS: The study supports recommending liners to patients who have a modest amount of fecal output or flatus. However, patients who are unable to manipulate the seal or have a large output volume are unlikely to find the liners a convenience. Satisfaction with the liners was sufficient to warrant investigation and design of a lined device with an improved design, greater capacity, and tighter seal.