Colonoscopy, Esophagogastroduodenoscopy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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)
Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation)
Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Sponsors
Study design
Eligibility
Inclusion criteria
* Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined Esophagogastroduodenoscopy and colonoscopy procedures at CCF. No additional intervention will be done other than the procedure they were scheduled for.
Exclusion criteria
1. Upper GI or lower GI bleeding at the time of procedure 2. Large amounts of vomiting reported before the procedure (with bowel preparation) 3. Hospital inpatients 4. History of abdominal surgery 5. History of gastroparesis or other documented GI transit disorder (ex. Colonic inertia) 6. Pregnancy Patients with diabetes mellitus taking Metoclopramide without proven gastroparesis by formal testing will not be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Gastric Volumes of Different Bowel Preparation Regimens | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pH of Gastric Fluid of Different Bowel Preparation Regimens | 1 day | 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. |
| Procedure Complications (Decrease in Oxygen Saturation) | 1 day | The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 187 |
| 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. | 241 |
| Total | 449 |
Baseline characteristics
| Characteristic | Evening Before Colonoscopy Preparation | Total | Split Dose Colonoscopy Preparation | Same Day Prep Colonoscopy Preparation |
|---|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 11 | 56 years STANDARD_DEVIATION 11.5 | 53 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 12 |
| Constipation | 19 participants | 34 participants | 3 participants | 12 participants |
| Diabetes Mellitus | 17 participants | 41 participants | 5 participants | 19 participants |
| Drugs affecting GI motility | 94 participants | 202 participants | 10 participants | 98 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 140 Participants | 5 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants | 297 Participants | 16 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 12 Participants | 0 Participants | 8 Participants |
| Last ingestion of clear liquids (hours) | 10.3 hours STANDARD_DEVIATION 4.6 | 7.7 hours STANDARD_DEVIATION 4.1 | 5.4 hours STANDARD_DEVIATION 1.9 | 5.8 hours STANDARD_DEVIATION 2.4 |
| Last ingestion of solids (hours) | 37.3 hours STANDARD_DEVIATION 9.8 | 38.4 hours STANDARD_DEVIATION 9.7 | 35.5 hours STANDARD_DEVIATION 8.7 | 39.4 hours STANDARD_DEVIATION 9.6 |
| PPI/H2 Blocker | 98 participants | 224 participants | 9 participants | 117 participants |
| Region of Enrollment United States | 187 participants | 449 participants | 21 participants | 241 participants |
| Sex: Female, Male Female | 116 Participants | 258 Participants | 11 Participants | 131 Participants |
| Sex: Female, Male Male | 71 Participants | 191 Participants | 10 Participants | 110 Participants |
| Volume of preparation: 4L | 101 participants | 277 participants | 21 participants | 155 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 187 | 0 / 241 |
| serious Total, serious adverse events | 0 / 21 | 0 / 187 | 0 / 241 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Split Dose Colonoscopy Preparation | Residual Gastric Volumes of Different Bowel Preparation Regimens | 19 mL | Standard Deviation 22 |
| Evening Before Colonoscopy Preparation | Residual Gastric Volumes of Different Bowel Preparation Regimens | 16 mL | Standard Deviation 16 |
| Same Day Prep Colonoscopy Preparation | Residual Gastric Volumes of Different Bowel Preparation Regimens | 18 mL | Standard Deviation 20 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Split Dose Colonoscopy Preparation | pH of Gastric Fluid of Different Bowel Preparation Regimens | 2.1 pH | Standard Deviation 1.5 |
| Evening Before Colonoscopy Preparation | pH of Gastric Fluid of Different Bowel Preparation Regimens | 2.5 pH | Standard Deviation 1.4 |
| Same Day Prep Colonoscopy Preparation | pH of Gastric Fluid of Different Bowel Preparation Regimens | 2.5 pH | Standard Deviation 3 |
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Split Dose Colonoscopy Preparation | Procedure Complications (Decrease in Oxygen Saturation) | 1 participants |
| Evening Before Colonoscopy Preparation | Procedure Complications (Decrease in Oxygen Saturation) | 6 participants |
| Same Day Prep Colonoscopy Preparation | Procedure Complications (Decrease in Oxygen Saturation) | 11 participants |