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The purpose of this study is to determine residual gastric volume and residual gastric pH in patients undergoing combined EGD and colonoscopy comparing the standard single dose prep with the split dose bowel preparation and same day bowel preparations.
The ASGE and ACG have developed standards for high-quality colonoscopy and ADR. Bowel cleansing must be optimal to enhance polyp detection and several studies have demonstrated the advantage of split dose or same day preparation as opposed to ingesting the preparation the day before. It is recommended that patients undergo split dosing of the bowel preparation or even same day bowel preparation for optimal cleansing. This is critical for high quality colonoscopy.
One of the risks associated with colonoscopy is pulmonary aspiration. Part of this risk may be related to retained gastric volume and gastric pH at the time of the endoscopic procedures. Aspiration pneumonia may be related to the acidity where more acidic aspirate may cause more severe respiratory compromise. In a recent article, Huffman supported the safety of split dose bowel preparation (4L bowel preparation) for outpatients undergoing colonoscopy. In this study it was/found that residual gastric volume in split dose preparations was higher than patients undergoing EGD alone but was not different from than in patients receiving bowel preparation the evening before. Early morning bowel preps for patients undergoing upper and lower endoscopies was not evaluated in this study. To our knowledge, the relationship of residual gastric volume in same day bowel preps has not been evaluated and has not been compared with the split dose bowel preps. A formal evaluation of difference in gastric acidity has not been evaluated in patients undergoing bowel prep for colonoscopy.
The study has a prospective observational design. The patients who have been already scheduled for a combined esophagogastroduodenoscopy and colonoscopy for their specific indications will be asked to be a part of this study. No additional intervention will be done other than the procedure they were already scheduled for. No specific interventions will be assigned to the subjects of the study. Outcomes will be assessed in pre-defined groups based on the bowel preparation taken by the patient.
The fluid is going to be collected in a suction container without solidifier material. Once the endoscopist enters the stomach all fluid will be suctioned which is part of the customary process of endoscopy. Once all fluid is aspirated, the container will be removed to empty the fluid into a measuring canister while the endoscopic procedure is continued and a container with solidifier material is instead connected to suction. The pH will be measured on the gastric fluid that was aspirated using a calibrated catheter pH device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split dose colonoscopy preparation | Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) |
| |
| Evening before colonoscopy preparation | Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) |
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| Same day prep colonoscopy preparation | Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogastroduodenoscopy and colonoscopy split dose prep | Other | Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive the Split dose colonoscopy prep split dose colonoscopy preparation- ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Gastric Volumes of Different Bowel Preparation Regimens | The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| pH of Gastric Fluid of Different Bowel Preparation Regimens | The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations. | 1 day |
| Procedure Complications (Decrease in Oxygen Saturation) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined Esophagogastroduodenoscopy and colonoscopy procedures at Cleveland Clinic Florida.
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| Name | Affiliation | Role |
|---|---|---|
| Alison Schneider, M.D. | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Split Dose Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep | Other | Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation) |
|
| Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation | Other | Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation) |
|
The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups. |
| 1 day |
| Evening Before Colonoscopy Preparation |
Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. |
| FG002 | Same Day Prep Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Split Dose Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. |
| BG001 | Evening Before Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. |
| BG002 | Same Day Prep Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes Mellitus | Number | participants |
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| Constipation | Number | participants |
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| PPI/H2 Blocker | Number | participants |
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| Drugs affecting GI motility | Number | participants |
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| Volume of preparation: 4L | Number | participants |
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| Last ingestion of solids (hours) | Mean | Standard Deviation | hours |
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| Last ingestion of clear liquids (hours) | Mean | Standard Deviation | hours |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Residual Gastric Volumes of Different Bowel Preparation Regimens | The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations. | Posted | Mean | Standard Deviation | mL | 1 day |
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| Secondary | pH of Gastric Fluid of Different Bowel Preparation Regimens | The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations. | Posted | Mean | Standard Deviation | pH | 1 day |
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| Secondary | Procedure Complications (Decrease in Oxygen Saturation) | The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups. | Posted | Number | participants | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Split Dose Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. | 0 | 21 | 0 | 21 | ||
| EG001 | Evening Before Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. | 0 | 187 | 0 | 187 | ||
| EG002 | Same Day Prep Colonoscopy Preparation | Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy. | 0 | 241 | 0 | 241 |
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The patients were not randomized to the two groups. Endoscopists were not blinded to the fact that patients were in the study but were unaware of the preparation type.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Schneider | Cleveland Clinic Florida | 954-659-5646 | schneia2@ccf.org |
| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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