Other Clinical Trial - The Effect of a 30-day Automated Text Messaging

Status Terminated

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

Clinical Trial Details

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

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See also
Status	Clinical Trial	Phase
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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
Completed	`NCT01994876` - Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy	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	`NCT03289013` - Assessement of the Peal Force Needed to Peel New Adhesives From the Skin	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
Completed	`NCT03770078` - Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms