Bowel Preparation Before Colonoscopy
Conditions
Keywords
colonoscopy, bowel preparation, inpatient, tolerability
Brief summary
Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.
Interventions
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or greater 4. Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone) 5. Ability to take bowel preparation and be willing to adhere to the regimen
Exclusion criteria
1. Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction 2. Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy 3. Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon 4. Unable to give informed consent to the procedure 5. Known glucose-6-phosphate dehydrogenase deficiency 6. Known phenylketonuria 7. Known hypersensitivity to polyethylene glycols or ascorbic acid 8. Patients undergoing colonoscopy for foreign body removal and/or decompression 9. Pregnancy or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adequate Bowel Preparation | At time of procedure, approximately 45 minutes | The Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment | At time of procedure, approximately 45 minutes | BBPS assesses three segments of the colon (left, transverse, right) and scores each segment either a 1, 2, or 3 based on the ability to visualize the mucosa. Higher scores correspond to improved mucosal visibility. |
| Number of Participants With "Excellent" Bowel Preparation | At time of procedure, approximately 45 minutes | The BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An excellent bowel preparation is defined as a BBPS score of an 8 or 9. |
| Cecal Intubation | At time of procedure, approximately 45 minutes | Number of participants with colonoscopies during which the cecum is successfully reached |
| Cecal Intubation Time | At time of procedure, approximately 45 minutes | Time from insertion of colonoscopy to reaching the cecum |
| Colonoscopy Withdrawal Time | At time of procedure, approximately 45 minutes | Time from reaching the cecum to complete withdrawal of the colonoscope |
| Time to Colonoscopy | From start of prep to time of procedure, up to 21 hours | The time from when the patient started the bowel preparation to the colonoscopy procedure itself. |
| Hospital Length of Stay | After study completion, an average of 10 days | Time from admission to discharge |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Through study completion, an average of 3 days | The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term from a scale of 1-5, with increasing score corresponding to increasing AE severity. |
| Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How much of the bowel preparation was left in the bottle after drinking it to your best effort?" |
| Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How tolerable did you find the bowel prep?" |
| Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Based on your current experience, would you be willing to drink the same prep again if you need another colonoscopy in the future?" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Gastric fullness" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Lack of sleep from excessive bathroom trips" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Nausea/vomiting" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bloating/abdominal distension/gas" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Abdominal pain/cramps" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bad taste in mouth" |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7 | Immediately prior to procedure | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Headache" |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDarrick K Li, MD, PhD
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64 years |
| Body Mass Index 18-24.9 kg/m^2 | 60 Participants |
| Body Mass Index <18 kg/m^2 | 11 Participants |
| Body Mass Index 25-29.9 kg/m^2 | 52 Participants |
| Body Mass Index 30-34.9 kg/m^2 | 51 Participants |
| Body Mass Index ≥35 kg/m^2 | 31 Participants |
| Body Mass Index Unknown | 0 Participants |
| Comorbidities Atrial Fibrillation | 47 Participants |
| Comorbidities Chronic Kidney Disease | 45 Participants |
| Comorbidities Cirrhosis | 30 Participants |
| Comorbidities Congestive Heart Failure | 50 Participants |
| Comorbidities Constipation | 48 Participants |
| Comorbidities Coronary Artery Disease | 54 Participants |
| Comorbidities COVID | 3 Participants |
| Comorbidities Dementia | 2 Participants |
| Comorbidities Diabetes | 53 Participants |
| Comorbidities Hypertension | 139 Participants |
| Comorbidities Malignancy | 40 Participants |
| Comorbidities Stroke | 34 Participants |
| Diet Prior to Colonoscopy Clear Liquid Diet | 185 Participants |
| Diet Prior to Colonoscopy Nil Per Os | 44 Participants |
| Diet Prior to Colonoscopy Other | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 354 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Indication for colonoscopy Abdominal Pain | 32 Participants |
| Indication for colonoscopy Abnormal Imaging | 47 Participants |
| Indication for colonoscopy Colon Cancer Screening/Surveillance | 17 Participants |
| Indication for colonoscopy Diarrhea | 41 Participants |
| Indication for colonoscopy Gastrointestinal Bleeding | 228 Participants |
| Indication for colonoscopy Inflammatory Bowel Disease | 8 Participants |
| Indication for colonoscopy Iron Deficiency Anemia | 52 Participants |
| Indication for colonoscopy Malignancy Workup | 18 Participants |
| Indication for colonoscopy Other | 12 Participants |
| Medication use Antihypertensive | 141 Participants |
| Medication use Antithrombotic | 97 Participants |
| Medication use Opioids | 119 Participants |
| Medication use Tricyclic Antidepressant | 5 Participants |
| Participant Baseline ASA Score 1- Healthy patient | 4 Participants |
| Participant Baseline ASA Score 2-Patient with mild systemic disease | 29 Participants |
| Participant Baseline ASA Score 3-Patient with severe systemic disease | 136 Participants |
| Participant Baseline ASA Score 4-Patient with severe systemic disease that is a constant threat to life | 43 Participants |
| Patient Location Emergency Department | 27 Participants |
| Patient Location Intensive Care Unit | 9 Participants |
| Patient Location Medical/Surgical Floor | 183 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 43 Participants |
| Race (NIH/OMB) White | 135 Participants |
| Region of Enrollment United States | 412 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 202 | 0 / 210 |
| other Total, other adverse events | 104 / 202 | 121 / 210 |
| serious Total, serious adverse events | 3 / 202 | 2 / 210 |
Outcome results
None listed