Abstract
BackgroundThe control of body waste emptying is a constant research topic in stoma care. The aim of this pilot study was to assess the efficacy and safety of an innovative colostomy appliance.MethodsAn interventional prospective non-comparative pilot study was conducted in seven French centers. The study device is a new type of two-piece appliance including a base plate and a “capsule cap” (CC) composed of a capsule cover and a folded collecting bag. The device gently seals the stoma to provide stoma output control. When the bowel movement pressure increases the patient may control the deployment of the folded bag and collect stools. Patients with left-sided colostomy all using a flat appliance, were enrolled in a 2-week trial. Outcome measures were type of CC removal and peristomal fecal leaks while wearing the device.ResultsOf 30 patients (females 66.7%), with left-sided colostomy (permanent 76.7%), 23 (76.7%) completed the 2-week trial. A total of 472 CC changes were analyzed. Efficacy: of 404 (85.5%) CC changes reported in diaries, 302 (74.8%) were linked with stool and/or gas. In 244 (60.3%) changes, the patient controlled stoma bag deployment and it occurred with bowel emptying 301 (74.5%) times. No leaks around the appliance were observed in 400 (85.3%) changes. Safety: no serious adverse event occurred. Peristomal skin was not modified during the trial.ConclusionsIn the short term this new device has provided an increased control over bowel emptying at no risk in half of the trial population suggesting that an alternative approach to bag wearing is achievable.
Highlights
It is estimated that as a result of disease, genetics or trauma, approximately 700,000 Europeans have had ostomy surgery to remove or divert diseased or damaged portions of their bowel or bladder [1]
Because of anxiety related to accidents and issues with stool leakage, odors and gas, many of them limit activities as they are worried about embarrassing situations in public [3]
When bowel emptying is completed, the bag can be disconnected from the base plate and discarded while a new capsule cap” (CC) is fixed on the same base plate
Summary
It is estimated that as a result of disease, genetics or trauma, approximately 700,000 Europeans have had ostomy surgery to remove or divert diseased or damaged portions of their bowel or bladder [1]. Because of anxiety related to accidents and issues with stool leakage, odors and gas, many of them limit activities as they are worried about embarrassing situations in public [3] They commonly feel their body out of control and report that pouch wearing has negative psychological impact [2, 3]. The control of body waste emptying is a constant research topic in stoma care The aim of this pilot study was to assess the efficacy and safety of an innovative colostomy appliance. In 244 (60.3%) changes, the patient controlled stoma bag deployment and it occurred with bowel emptying 301 (74.5%) times. Conclusions In the short term this new device has provided an increased control over bowel emptying at no risk in half of the trial population suggesting that an alternative approach to bag wearing is achievable
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
