View clinical trials related to Ileostomy.
Filter by:The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.
One of the main reasons for hospital readmission in ileostomy patients is fluid and electrolyte abnormalities. Prospective observational studies have suggested an occurrence rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium and fluid through their stoma effluent. In addition studies have shown that ileostomy construction is a risk factor for renal impairment, occurring secondary to dehydration. Encouraging patients to increase total fluid intake seems to be a common mistake in clinical practice as this can dilute sodium levels even more, causing greater sodium depletion. In terms of addressing the problem a few small studies have used isotonic drinks of various compositions showing increased electrolyte absorption. Other dietary complications sometimes include hypomagnesaemia and decreased absorption of B-12 and folic acid, however due to the integrity of the small intestine other nutrient malabsorption is unlikely to occur. As far as body composition is concerned obesity has been shown to be a risk factor for peri- and postoperative complications in colorectal surgery (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining measures that can prevent readmission for dehydration and other nutritional considerations related to this group of patients is definitely required. Hypothesis: The administration of an oral rehydration solution will allow a significant decrease in dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices. The secondary objective is to investigate several performance and safety parameters of the various devices. The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed. Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development. The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users. Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.
Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.