Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding

NCT05170945 | Unknown

• 1 other identifier: 003.GID.2020.D
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Units of RBC transfused

  5 years of data will be collected

• Colonoscopy details

  5 years of data will be collected

• Therapeutic Hemostasis Invervention

  After discharge

• Radiographic Studies

  5 years of data will be collected

Study Arms (2)

Retrospective Cohort

NO INTERVENTION

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

Prospective Cohort

EXPERIMENTAL

Early bowel preparation for colonoscopy patients

Other: Early bowel preparation for colonoscopy

Interventions

Early bowel preparation for colonoscopy OTHER

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

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Diverticular Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Prashant Kedia, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette Ngo Ndjom

CONTACT

214 947 1280; ClinicalResearch@mhd.com

Ashley Haider

CONTACT

214 947 1280; ClinicalResearch@mhd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: December 28, 2021
• Study Start: March 28, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

US (1)