Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding

NCT ID: NCT05170945

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2024-05-31

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).

Conditions

Diverticular Bleeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retrospective Cohort

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Prospective Cohort

Early bowel preparation for colonoscopy patients

Group Type: EXPERIMENTAL

Early bowel preparation for colonoscopy

Intervention Type: OTHER

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

Interventions

Early bowel preparation for colonoscopy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prashant Kedia, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colette Ngo Ndjom

Role: CONTACT

ClinicalResearch@mhd.com

214 947 1280

Ashley Haider

Role: CONTACT

ClinicalResearch@mhd.com

214 947 1280

Facility Contacts

Prashant Kedia, MD

Role: primary

Other Identifiers

003.GID.2020.D

Identifier Type: -

Identifier Source: org_study_id