Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT05170945

Conditions

Diverticular Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early bowel preparation for colonoscopy

Study Details

Brief summary:

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.

Conditions

Diverticular Bleeding

Study ID

NCT05170945

Start date

Mar 28, 2023

Status verified date

Mar, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient admitted to Methodist Dallas Medical Center
  • Age greater than 18 years
  • Patient evaluated by gastroenterology consult service during admission
  • Hospitalization with diagnosis of "hematochezia", "acute gastrointestinal bleeding", "acute blood loss anemia", or "anemia"
  • Endorsed or witnessed episode of painless hematochezia
  • Patients exhibiting hemodynamic stability (heart rate <110; systolic blood pressure >90) after initial evaluation and resuscitation by admitting/emergency room physicians

Exclusion Criteria:

  • Age less than 18 years
  • Persistent hypotension despite initial intravenous fluid resuscitation or fever
  • Bowel preparation started 24 hours after initial presentation
  • Documented symptoms of dysphagia or odynophagia
  • Signs or symptoms suggestive of gastrointestinal obstruction (or ileus) on initial presentation (e.g., abdominal pain, nausea and/or vomiting)
  • Inability to complete bowel preparation
  • Personal history of inflammatory bowel disease or cirrhosis
  • History of immunosuppression (e.g., AIDS, immunosuppressive medication)
  • Personal history of colon cancer
  • Prior gastric bypass, small bowel, or colonic resection
  • Stool culture positive for tested organisms to include Clostridium difficile

Study Design

Enrollment

415 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Retrospective Cohort

Colonoscopy was performed, either early bowel preparation, late bowel preparation or no bowel preparation patients.

experimental: Prospective Cohort

Early bowel preparation for colonoscopy patients

Interventions

Early bowel preparation for colonoscopy

Early (<24 hours) bowel cleansing prior to colonoscopy.

Primary outcome measure

  • Hospital length of stay [ Time Frame: 5 years of data will be collected ]

Central Contacts and Locations

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Principal Investigator:

Prashant Kedia, MD

More Information

Sponsor

Methodist Health System

Last update posted

Mar 31, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2023-03-31.