Diverticular BleedingNCT05170945
Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding
A study testing Early bowel preparation for colonoscopy in people with Diverticular Bleeding, run by Methodist Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Bleeding
- What is being tested?
- Early bowel preparation for colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Prashant Kedia, MD
Prashant Kedia, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Early bowel preparation for colonoscopy
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early bowel preparation for colonoscopyOther
Early (<24 hours) bowel cleansing prior to colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Early bowel preparation for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Hospital length of stay in the early bowel preparation, late bowel preparation, and no bowel preparation groups.
Measured: 5 years of data will be collected
Secondary outcomes (4)
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.
Measured: 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.
Measured: 5 years of data will be collected
Therapeutic Hemostasis Invervention
- If a colonoscopy was performed, was therapeutic hemostasis intervention performed.
Measured: After discharge
Radiographic Studies
Number and type of radiographic studies performed to identify source of bleeding.
Measured: 5 years of data will be collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start28 Mar 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prashant Kedia, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170945
- Sponsor's protocol ID
- 003.GID.2020.D
- Status last verified
- Mar 2023
- First submitted
- 22 Sep 2020
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Routine Bowel Preparation for Suspected Acute Diverticular Bleeding: A Quality Improvement Initiative Analyzing Hospital Length of Stay
- ClinicalTrials.gov ID
- NCT05170945
- Acronym / sponsor ID
- 003.GID.2020.D
- Conditions
- Diverticular Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | No intervention | –Colonoscopy was performed, either early bowel preparation, late bowel preparation or no bowel preparation patients. |
| Prospective Cohort | Experimental | Other: Early bowel preparation for colonoscopyEarly bowel preparation for colonoscopy patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early bowel preparation for colonoscopyEarly (<24 hours) bowel cleansing prior to colonoscopy. | Other | Prospective Cohort |
Primary outcome
Hospital length of stay
Time frame: 5 years of data will be collected
Hospital length of stay in the early bowel preparation, late bowel preparation, and no bowel preparation groups.
4 secondary outcomes
Units of RBC transfused
Time frame: 5 years of data will be collected
Colonoscopy details
Time frame: 5 years of data will be collected
Therapeutic Hemostasis Invervention
Time frame: After discharge
Radiographic Studies
Time frame: 5 years of data will be collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashant Kedia, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early bowel preparation for colonoscopy in people with Diverticular Bleeding, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette Ngo Ndjom (214 947 1280, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: 5 years of data will be collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.