Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diverticular Bleeding
• Intervention / Treatment: Other: Early bowel preparation for colonoscopy

Detailed Description

This investigation will utilize both a five-year retrospective analysis and a two-year prospective investigation. Patient cohorts and data will be obtained through utilization of the EPIC electronic medical record (EMR) and generating an individualized report to capture all possible patients. The report will include all admitted patients with a consult note written by the gastroenterology consult service at Methodist Dallas Medical Center. The consult note will be reviewed, and any patient not meeting the inclusion criteria or those meeting any of the exclusion criteria will be excluded. The patients remaining after this assessment will be included in the retrospective analysis. 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. The gastroenterology consult service will assess patients with lower GI bleeding with the inclusion and exclusion criteria. Those who qualify will be provided informed consent forms and offered the opportunity to enroll in the study. 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. The study is not evaluating effects of colonoscopy, and so any additional intervention performed by the attending gastroenterologist will be subject to their own discretion after the completion of the bowel preparation. After discharge, patient information and data variables will be collected from the EPIC EMR and included in an Excel document. 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. Disclaimer: Any cost associated with the procedures stated herein will be billed directly to insurance (as applicable).

• Study Type: Interventional
• Enrollment (Anticipated): 415
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Haider; Phone Number: 214 947 1280; Email: ClinicalResearch@mhd.com
• Study Contact Backup: Name: Colette Ngo Ndjom; Phone Number: 214 947 1280; Email: ClinicalResearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Principal Investigator: Prashant Kedia, MD
      • Sub-Investigator: Bryce Bushe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Early bowel preparation for colonoscopy; Early (<24 hours) bowel cleansing prior to colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Hospital length of stay in the early bowel preparation, late bowel preparation, and no bowel preparation groups.	5 years of data will be collected

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Units of RBC transfused	The difference in average units of packed red blood cells transfused during the hospital stay between early, late, and no preparation groups.	5 years of data will be collected
Colonoscopy details	Whether a colonoscopy was performed during hospitalization, the diagnosis at time of colonoscopy, and presence of anticoagulation medications.	5 years of data will be collected
Therapeutic Hemostasis Invervention	• If a colonoscopy was performed, was therapeutic hemostasis intervention performed.	After discharge
Radiographic Studies	Number and type of radiographic studies performed to identify source of bleeding.	5 years of data will be collected

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Prashant Kedia, MD, Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Hemorrhage; Diverticular Diseases
• Other Study ID Numbers: 003.GID.2020.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No