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Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation

Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02264249
Enrollment
449
Registered
2014-10-15
Start date
2014-09-30
Completion date
2016-02-29
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Esophagogastroduodenoscopy

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

OTHEREsophagogastroduodenoscopy and colonoscopy split dose prep

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)

OTHEREsophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep

Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation)

OTHEREsophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation

Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation)

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Residual Gastric Volumes of Different Bowel Preparation Regimens1 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.

Secondary

MeasureTime frameDescription
pH of Gastric Fluid of Different Bowel Preparation Regimens1 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.
Procedure Complications (Decrease in Oxygen Saturation)1 dayThe 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

ArmCount
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
Total449

Baseline characteristics

CharacteristicEvening Before Colonoscopy PreparationTotalSplit Dose Colonoscopy PreparationSame Day Prep Colonoscopy Preparation
Age, Continuous56 years
STANDARD_DEVIATION 11
56 years
STANDARD_DEVIATION 11.5
53 years
STANDARD_DEVIATION 13
56 years
STANDARD_DEVIATION 12
Constipation19 participants34 participants3 participants12 participants
Diabetes Mellitus17 participants41 participants5 participants19 participants
Drugs affecting GI motility94 participants202 participants10 participants98 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
62 Participants140 Participants5 Participants73 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
121 Participants297 Participants16 Participants160 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants12 Participants0 Participants8 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 Blocker98 participants224 participants9 participants117 participants
Region of Enrollment
United States
187 participants449 participants21 participants241 participants
Sex: Female, Male
Female
116 Participants258 Participants11 Participants131 Participants
Sex: Female, Male
Male
71 Participants191 Participants10 Participants110 Participants
Volume of preparation: 4L101 participants277 participants21 participants155 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 210 / 1870 / 241
serious
Total, serious adverse events
0 / 210 / 1870 / 241

Outcome results

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.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Split Dose Colonoscopy PreparationResidual Gastric Volumes of Different Bowel Preparation Regimens19 mLStandard Deviation 22
Evening Before Colonoscopy PreparationResidual Gastric Volumes of Different Bowel Preparation Regimens16 mLStandard Deviation 16
Same Day Prep Colonoscopy PreparationResidual Gastric Volumes of Different Bowel Preparation Regimens18 mLStandard Deviation 20
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.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Split Dose Colonoscopy PreparationpH of Gastric Fluid of Different Bowel Preparation Regimens2.1 pHStandard Deviation 1.5
Evening Before Colonoscopy PreparationpH of Gastric Fluid of Different Bowel Preparation Regimens2.5 pHStandard Deviation 1.4
Same Day Prep Colonoscopy PreparationpH of Gastric Fluid of Different Bowel Preparation Regimens2.5 pHStandard Deviation 3
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.

Time frame: 1 day

ArmMeasureValue (NUMBER)
Split Dose Colonoscopy PreparationProcedure Complications (Decrease in Oxygen Saturation)1 participants
Evening Before Colonoscopy PreparationProcedure Complications (Decrease in Oxygen Saturation)6 participants
Same Day Prep Colonoscopy PreparationProcedure Complications (Decrease in Oxygen Saturation)11 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026