View clinical trials related to Ileostomy - Stoma.
Filter by:The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
To investigate the performance and safety of the three 2-piece convex ostomy appliances
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
Dietary fiber is a type of carbohydrate which is not digested in the human small intestine. Whole grains are a source of dietary fiber that are used to promote health; however, using whole grains in commercial products results in a different taste and/or texture than the usual products made from refined grains. Thus, other types of high-fiber ingredients have been developed which can be incorporated into food products with less effect on their taste and/or texture. An example of this is resistant starch, defined as starch which is not digested in the human small intestine. The digestibility of starch is usually determined in-vitro; however, there is evidence that such methods may overestimate the amount of resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best in-vivo method of starch digestibility. The subjects collect ileal effluent during the day during which time they consume a polysaccharide-free diet. There is evidence that resistant starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after consumption. The purpose of this study will be to compare the carbohydrate content recovered in ileal effluent of 10 subjects with a conventional ileostomy.
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures. Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
Consenting subjects will be randomized to receive injection of bupivacaine or placebo before surgery for ileostomy takedown (injection administered after general anesthesia has been administered). Pain and side effects will be assessed periodically after surgery using the verbal Numeric Rating pain Scores, including at the timepoint of 24 hours after surgery. All subjects in this study will be given toradol to ensure adequate pain control.
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
The aim of the current clinical investigation is to evaluate a new filter
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.