Open AccessA Prospective, Randomized Cross‐over Trial of 2 Low‐profile Gastrostomy Buttons to Determine Family Preference
Author(s) -
Abdelhadi Ruba A.,
Dekonenko Charlene,
Dorman Robert M.,
Oyetunji Tolulope A.,
St. Peter Shawn D.
Publication year - 2020
Publication title -
journal of pediatric gastroenterology and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 131
eISSN - 1536-4801
pISSN - 0277-2116
DOI - 10.1097/mpg.0000000000002585
Subject(s) - medicine , crossover study , randomized controlled trial , tube (container) , gastrostomy tube , gastrostomy , surgery , population , mechanical engineering , alternative medicine , environmental health , pathology , engineering , placebo
Low‐profile gastrostomy balloon buttons are often used in the pediatric population. We conducted a prospective, randomized crossover trial to determine family preference comparing MIC‐KEY (tube A) and MiniONE (tube B) buttons. Patients were randomized to tube A and tube B at placement. At 2 months, patients were given the opposite button. At 4 months, parents indicated their preferred button. A standardized assessment tool was used to assess gastrostomy site skin complications and device malfunction. One hundred fifty‐eight patients were randomized, 79 each to receive tube A or tube B first. Sixty‐eight with tube A and 60 with tube B completed their first follow‐up. Sixty‐five with tube A and 43 with tube B completed crossover, 69% of whom preferred tube B ( P < 0.001). Including those who preferred their first button and declined to switch at 2 months, 91 of 127 (72%) kept tube B, demonstrating a strong preference for tube B.