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Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding

Primary Purpose

Diverticular Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early bowel preparation for colonoscopy
Sponsored by
Methodist Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticular Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Methodist Dallas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Retrospective Cohort

Prospective Cohort

Arm Description

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

Early bowel preparation for colonoscopy patients

Outcomes

Primary Outcome Measures

Hospital length of stay
Hospital length of stay in the early bowel preparation, late bowel preparation, and no bowel preparation groups.

Secondary Outcome Measures

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.
Colonoscopy details
Whether a colonoscopy was performed during hospitalization, the diagnosis at time of colonoscopy, and presence of anticoagulation medications.
Therapeutic Hemostasis Invervention
• If a colonoscopy was performed, was therapeutic hemostasis intervention performed.
Radiographic Studies
Number and type of radiographic studies performed to identify source of bleeding.

Full Information

First Posted
September 22, 2020
Last Updated
March 30, 2023
Sponsor
Methodist Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05170945
Brief Title
Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding
Official Title
Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding: A Quality Improvement Initiative Analyzing Hospital Length of Stay
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Methodist Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticular Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
415 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrospective Cohort
Arm Type
No Intervention
Arm Description
Colonoscopy was performed, either early bowel preparation, late bowel preparation or no bowel preparation patients.
Arm Title
Prospective Cohort
Arm Type
Experimental
Arm Description
Early bowel preparation for colonoscopy patients
Intervention Type
Other
Intervention Name(s)
Early bowel preparation for colonoscopy
Intervention Description
Early (<24 hours) bowel cleansing prior to colonoscopy.
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
Hospital length of stay in the early bowel preparation, late bowel preparation, and no bowel preparation groups.
Time Frame
5 years of data will be collected
Secondary Outcome Measure Information:
Title
Units of RBC transfused
Description
The difference in average units of packed red blood cells transfused during the hospital stay between early, late, and no preparation groups.
Time Frame
5 years of data will be collected
Title
Colonoscopy details
Description
Whether a colonoscopy was performed during hospitalization, the diagnosis at time of colonoscopy, and presence of anticoagulation medications.
Time Frame
5 years of data will be collected
Title
Therapeutic Hemostasis Invervention
Description
• If a colonoscopy was performed, was therapeutic hemostasis intervention performed.
Time Frame
After discharge
Title
Radiographic Studies
Description
Number and type of radiographic studies performed to identify source of bleeding.
Time Frame
5 years of data will be collected

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colette Ngo Ndjom
Phone
214 947 1280
Email
ClinicalResearch@mhd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Haider
Phone
214 947 1280
Email
ClinicalResearch@mhd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashant Kedia, MD
Organizational Affiliation
Methodist Dallas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prashant Kedia, MD
First Name & Middle Initial & Last Name & Degree
Prashant Kedia, MD
First Name & Middle Initial & Last Name & Degree
Bryce Bushe, MD

12. IPD Sharing Statement

Learn more about this trial

Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding

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