RECRUITING

Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This investigation will utilize both a five-year retrospective analysis and a two-year prospective investigation. Variables including age; gender; presence of anticoagulation medication; hospital length of stay; total transfused red blood cell units; presence of heart failure, chronic kidney disease, or lung disease; history of diverticular disease; whether colonoscopy was performed; if therapeutic hemostasis was performed during colonoscopy; and information regarding prior colonoscopies in the past 10 years will be collected for analysis. A small number of early bowel preparation patients are expected in the retrospective study; therefore, a prospective study occurring over the next 12 months will be conducted. Patients agreeing to participate in the study would have a four-liter dose of PEG 3350 ordered, and the medication would be delivered within the first 24 hours of hospitalization. Radiographic studies including computed tomography angiography, tagged RBC scan, and angiography will not be obtained in the first 24 hours of hospital admission and be considered only if the patient has ongoing hematochezia at the completion of their bowel preparation. After completion of the 12-month investigative period (or earlier if sufficient sample size is obtained for clinical significance), data will be analyzed for dissemination consideration.

Official Title

Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding: A Quality Improvement Initiative Analyzing Hospital Length of Stay

Quick Facts

Study Start:2023-03-28
Study Completion:2024-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05170945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient admitted to Methodist Dallas Medical Center
  2. * Age greater than 18 years
  3. * Patient evaluated by gastroenterology consult service during admission
  4. * Hospitalization with diagnosis of "hematochezia", "acute gastrointestinal bleeding", "acute blood loss anemia", or "anemia"
  5. * Endorsed or witnessed episode of painless hematochezia
  6. * Patients exhibiting hemodynamic stability (heart rate \<110; systolic blood pressure \>90) after initial evaluation and resuscitation by admitting/emergency room physicians
  1. * Age less than 18 years
  2. * Persistent hypotension despite initial intravenous fluid resuscitation or fever
  3. * Bowel preparation started 24 hours after initial presentation
  4. * Documented symptoms of dysphagia or odynophagia
  5. * Signs or symptoms suggestive of gastrointestinal obstruction (or ileus) on initial presentation (e.g., abdominal pain, nausea and/or vomiting)
  6. * Inability to complete bowel preparation
  7. * Personal history of inflammatory bowel disease or cirrhosis
  8. * History of immunosuppression (e.g., AIDS, immunosuppressive medication)
  9. * Personal history of colon cancer
  10. * Prior gastric bypass, small bowel, or colonic resection
  11. * Stool culture positive for tested organisms to include Clostridium difficile

Contacts and Locations

Study Contact

Colette Ngo Ndjom
CONTACT
214 947 1280
ClinicalResearch@mhd.com
Ashley Haider
CONTACT
214 947 1280
ClinicalResearch@mhd.com

Principal Investigator

Prashant Kedia, MD
PRINCIPAL_INVESTIGATOR
Methodist Dallas Medical Center

Study Locations (Sites)

Methodist Dallas Medical Center
Dallas, Texas, 75203
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Prashant Kedia, MD, PRINCIPAL_INVESTIGATOR, Methodist Dallas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-28
Study Completion Date2024-05

Study Record Updates

Study Start Date2023-03-28
Study Completion Date2024-05

Terms related to this study

Additional Relevant MeSH Terms

  • Diverticular Bleeding