Trial Outcomes & Findings for Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation (NCT NCT02264249)
NCT ID: NCT02264249
Last Updated: 2017-05-17
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
449 participants
Primary outcome timeframe
1 day
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
187
|
241
|
|
Overall Study
COMPLETED
|
21
|
187
|
241
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation
Baseline characteristics by cohort
| Measure |
Split Dose Colonoscopy Preparation
n=21 Participants
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.
|
Evening Before Colonoscopy Preparation
n=187 Participants
Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.
|
Same Day Prep Colonoscopy Preparation
n=241 Participants
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.
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11 • n=7 Participants
|
56 years
STANDARD_DEVIATION 12 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
187 participants
n=7 Participants
|
241 participants
n=5 Participants
|
449 participants
n=4 Participants
|
|
Diabetes Mellitus
|
5 participants
n=5 Participants
|
17 participants
n=7 Participants
|
19 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Constipation
|
3 participants
n=5 Participants
|
19 participants
n=7 Participants
|
12 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
PPI/H2 Blocker
|
9 participants
n=5 Participants
|
98 participants
n=7 Participants
|
117 participants
n=5 Participants
|
224 participants
n=4 Participants
|
|
Drugs affecting GI motility
|
10 participants
n=5 Participants
|
94 participants
n=7 Participants
|
98 participants
n=5 Participants
|
202 participants
n=4 Participants
|
|
Volume of preparation: 4L
|
21 participants
n=5 Participants
|
101 participants
n=7 Participants
|
155 participants
n=5 Participants
|
277 participants
n=4 Participants
|
|
Last ingestion of solids (hours)
|
35.5 hours
STANDARD_DEVIATION 8.7 • n=5 Participants
|
37.3 hours
STANDARD_DEVIATION 9.8 • n=7 Participants
|
39.4 hours
STANDARD_DEVIATION 9.6 • n=5 Participants
|
38.4 hours
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Last ingestion of clear liquids (hours)
|
5.4 hours
STANDARD_DEVIATION 1.9 • n=5 Participants
|
10.3 hours
STANDARD_DEVIATION 4.6 • n=7 Participants
|
5.8 hours
STANDARD_DEVIATION 2.4 • n=5 Participants
|
7.7 hours
STANDARD_DEVIATION 4.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayThe residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.
Outcome measures
| Measure |
Split Dose Colonoscopy Preparation
n=21 Participants
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.
|
Evening Before Colonoscopy Preparation
n=187 Participants
Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.
|
Same Day Prep Colonoscopy Preparation
n=241 Participants
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.
|
|---|---|---|---|
|
Residual Gastric Volumes of Different Bowel Preparation Regimens
|
19 mL
Standard Deviation 22
|
16 mL
Standard Deviation 16
|
18 mL
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 1 dayThe 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.
Outcome measures
| Measure |
Split Dose Colonoscopy Preparation
n=21 Participants
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.
|
Evening Before Colonoscopy Preparation
n=187 Participants
Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.
|
Same Day Prep Colonoscopy Preparation
n=241 Participants
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.
|
|---|---|---|---|
|
pH of Gastric Fluid of Different Bowel Preparation Regimens
|
2.1 pH
Standard Deviation 1.5
|
2.5 pH
Standard Deviation 1.4
|
2.5 pH
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 1 dayThe patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.
Outcome measures
| Measure |
Split Dose Colonoscopy Preparation
n=21 Participants
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.
|
Evening Before Colonoscopy Preparation
n=187 Participants
Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.
|
Same Day Prep Colonoscopy Preparation
n=241 Participants
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.
|
|---|---|---|---|
|
Procedure Complications (Decrease in Oxygen Saturation)
|
1 participants
|
6 participants
|
11 participants
|
Adverse Events
Split Dose Colonoscopy Preparation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evening Before Colonoscopy Preparation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Same Day Prep Colonoscopy Preparation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place