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Early Bowel Preparation for Diverticulosis Bleeding

N/A
Recruiting
Led By Prashant Kedia, MD
Research Sponsored by Methodist Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients exhibiting hemodynamic stability (heart rate <110; systolic blood pressure >90) after initial evaluation and resuscitation by admitting/emergency room physicians
Endorsed or witnessed episode of painless hematochezia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of data will be collected
Awards & highlights

Study Summary

This trial will use data from past patients and from those who agree to participate over the next 12 months to study the effects of a 4-liter dose of PEG 3350 on patients with hemorrhaging.

Who is the study for?
This trial is for adults over 18 admitted to Methodist Dallas Medical Center with a diagnosis related to acute gastrointestinal bleeding and stable vital signs after initial treatment. It's not for those who started bowel prep late, have immune system issues, tested positive for certain infections, show signs of GI obstruction or have a history of specific GI diseases.Check my eligibility
What is being tested?
The study tests early bowel preparation using PEG 3350 within the first day of hospitalization in patients with suspected diverticular bleeding. The aim is to see if this leads to better outcomes compared to later or no bowel preparation.See study design
What are the potential side effects?
While the trial focuses on timing and effectiveness rather than medication side effects, typical reactions from PEG 3350 can include bloating, nausea, cramping, and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart rate is under 110 and my blood pressure is over 90 after initial treatment.
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I have experienced painless bleeding from my rectum.
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I was hospitalized for bleeding in my stool or severe anemia.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of data will be collected
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of data will be collected for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital length of stay
Secondary outcome measures
Colonoscopy details
Radiographic Studies
Hemostatic function
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective CohortExperimental Treatment1 Intervention
Early bowel preparation for colonoscopy patients
Group II: Retrospective CohortActive Control1 Intervention
Colonoscopy was performed, either early bowel preparation, late bowel preparation or no bowel preparation patients.

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor
152 Previous Clinical Trials
4,825,218 Total Patients Enrolled
Prashant Kedia, MDPrincipal InvestigatorMethodist Dallas Medical Center
8 Previous Clinical Trials
681 Total Patients Enrolled

Media Library

Early bowel preparation for colonoscopy Clinical Trial Eligibility Overview. Trial Name: NCT05170945 — N/A
Diverticulosis Bleeding Research Study Groups: Prospective Cohort, Retrospective Cohort
Diverticulosis Bleeding Clinical Trial 2023: Early bowel preparation for colonoscopy Highlights & Side Effects. Trial Name: NCT05170945 — N/A
Early bowel preparation for colonoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05170945 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being sought to join this experiment?

"Affirmative, clinicaltrials.gov data confirms that this medical trial is in the midst of recruitment and was first made public on May 6th 2020. It requires 415 participants to be recruited from one site before it can proceed further."

Answered by AI

To what extent is this experiment engaging participants?

"That is correct. According to the information on clinicaltrials.gov, this medical trial was first posted in May of 2020 and remains open for recruitment with a target of 415 participants from one location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding
2023. "Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05170945.
~0 spots leftby May 2024
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