Clinical Trials Logo

Clinical Trial Summary

Each year a large number of patients undergo ileostomy surgery, a procedure in which a portion of the small intestine is attached to a hole in the abdominal wall, allowing for digested material to pass into a disposable bag worn attached to the skin. Ileostomies are performed for the treatment of a variety of diseases of the intestinal tract, such as inflammatory bowel disease, intestinal trauma, and gastrointestinal malignancy. Of the patients that undergo ileostomy surgery, 36% will require urgent medical care within the first 30 days of surgery. Most frequently, this is a result of dehydration due to excessive ostomy output. Thus, there is potential for significant improvement of the post-operative outcomes of ileostomy patients. Implementation of an automated text messaging system, EpxOstomy, can provide a way of monitoring patient's daily ostomy output and allow for timely intervention if output is outside normal limits, providing an effective way of improving patient outcomes while simultaneously reducing healthcare costs.


Clinical Trial Description

Each year thousands of patients undergo ostomy surgery in the treatment of diseases such as colorectal cancer, Crohn's disease, diverticulitis, and ulcerative colitis. During the 30-day post-operative period, patients that undergo ileostomy have a 36.1% rate of acute healthcare encounter compared to 16.2% of patients undergoing similar surgery but with primary anastomosis. The 30-day hospital readmission rate for ileostomy patients due to dehydration and renal failure is 17%, with the median cost per colorectal surgery readmission being $8,885. Thus, there is substantial room for post-operative improvement in the care of ileostomy patients, both to reduce healthcare costs and improve patient quality of life. An automated text messaging system can provide a way to consistently monitor patients' ileostomy output, ensuring that patients are measuring their daily output as instructed and allowing for timely preemptive intervention should output be outside normal limits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03424954
Study type Interventional
Source St. Louis University
Contact
Status Terminated
Phase N/A
Start date March 1, 2018
Completion date March 31, 2019

See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Completed NCT03331783 - Assessment of the Effect of Output on New Adhesives N/A
Completed NCT02886455 - Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives N/A
Completed NCT02920294 - Modulation of Microbial Composition in Ileostomy Patients N/A
Completed NCT02517541 - A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products N/A
Completed NCT01957553 - Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece N/A
Completed NCT01939600 - Digestibility of Selected Resistant Starches in Humans N/A
Terminated NCT01994863 - Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy Phase 2
Completed NCT01994876 - Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy N/A
Completed NCT03289013 - Assessement of the Peal Force Needed to Peel New Adhesives From the Skin N/A
Terminated NCT03416023 - Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy N/A
Completed NCT02997267 - Early Closure of Protective Ileostomy in Rectal Cancer Patients N/A
Recruiting NCT01880918 - A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing N/A
Completed NCT01957397 - Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy N/A
Recruiting NCT04577456 - Chyme Reinfusion for Type 2 Intestinal Failure N/A
Terminated NCT03587519 - Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery N/A
Recruiting NCT03872271 - Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial N/A
Completed NCT04606004 - Perianal Maceration in Pediatric Ostomy Closure Patients N/A
Completed NCT02886403 - Evaluation of the Influence of Output on a Newly Develop Adhesive N/A
Recruiting NCT03424447 - Stimulation of the Efferent Loop Before Loop Ileostomy Closure Phase 2