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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02264249
• Collaborator: (none)
• Enrollment: 449
• Location: 1
• Duration (Months): 17
• Patients Per Site Per Month: 26.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophagogastroduodenoscopy; Colonoscopy	Other: Esophagogastroduodenoscopy and colonoscopy split dose prep; Other: Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep; Other: Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 449 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation: A Prospective Observational Study
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Split dose colonoscopy preparation Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)	Other: Esophagogastroduodenoscopy 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)
Evening before colonoscopy preparation Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)	Other: Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep; Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation)
Same day prep colonoscopy preparation Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)	Other: Esophagogastroduodenoscopy 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)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Florida	Weston	Florida	United States	33331

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Alison Schneider, M.D., Cleveland Clinic Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alison Schneider, Staff Physician, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02264249
• Other Study ID Numbers: FLA 14-086
• First Posted: Oct 15, 2014
• Last Update Posted: May 17, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Split Dose Colonoscopy Preparation	Evening Before Colonoscopy Preparation	Same Day Prep Colonoscopy Preparation
Arm/Group Description	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.	Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.	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.
Period Title: Overall Study
STARTED	21	187	241
COMPLETED	21	187	241
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Split Dose Colonoscopy Preparation	Evening Before Colonoscopy Preparation	Same Day Prep Colonoscopy Preparation	Total
Arm/Group Description	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.	Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.	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 of all reporting groups
Overall Participants	21	187	241	449
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (13)	56 (11)	56 (12)	56 (11.5)
Sex: Female, Male (Count of Participants)
Female	11 52.4%	116 62%	131 54.4%	258 57.5%
Male	10 47.6%	71 38%	110 45.6%	191 42.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 23.8%	62 33.2%	73 30.3%	140 31.2%
Not Hispanic or Latino	16 76.2%	121 64.7%	160 66.4%	297 66.1%
Unknown or Not Reported	0 0%	4 2.1%	8 3.3%	12 2.7%
Region of Enrollment (participants) [Number]
United States	21 100%	187 100%	241 100%	449 100%
Diabetes Mellitus (participants) [Number]
Number [participants]	5 23.8%	17 9.1%	19 7.9%	41 9.1%
Constipation (participants) [Number]
Number [participants]	3 14.3%	19 10.2%	12 5%	34 7.6%
PPI/H2 Blocker (participants) [Number]
Number [participants]	9 42.9%	98 52.4%	117 48.5%	224 49.9%
Drugs affecting GI motility (participants) [Number]
Number [participants]	10 47.6%	94 50.3%	98 40.7%	202 45%
Volume of preparation: 4L (participants) [Number]
Number [participants]	21 100%	101 54%	155 64.3%	277 61.7%
Last ingestion of solids (hours) (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	35.5 (8.7)	37.3 (9.8)	39.4 (9.6)	38.4 (9.7)
Last ingestion of clear liquids (hours) (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	5.4 (1.9)	10.3 (4.6)	5.8 (2.4)	7.7 (4.1)

Outcome Measures

1. Primary Outcome

Title	Residual Gastric Volumes of Different Bowel Preparation Regimens
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Split Dose Colonoscopy Preparation	Evening Before Colonoscopy Preparation	Same Day Prep Colonoscopy Preparation
Arm/Group Description	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.	Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.	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.
Measure Participants	21	187	241
Mean (Standard Deviation) [mL]	19 (22)	16 (16)	18 (20)

2. Secondary Outcome

Title	pH of Gastric Fluid of Different Bowel Preparation Regimens
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Split Dose Colonoscopy Preparation	Evening Before Colonoscopy Preparation	Same Day Prep Colonoscopy Preparation
Arm/Group Description	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.	Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.	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.
Measure Participants	21	187	241
Mean (Standard Deviation) [pH]	2.1 (1.5)	2.5 (1.4)	2.5 (3)

3. Secondary Outcome

Title	Procedure Complications (Decrease in Oxygen Saturation)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Split Dose Colonoscopy Preparation	Evening Before Colonoscopy Preparation	Same Day Prep Colonoscopy Preparation
Arm/Group Description	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.	Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.	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.
Measure Participants	21	187	241
Number [participants]	1 4.8%	6 3.2%	11 4.6%

Adverse Events

Arm/Group Title	Split Dose Colonoscopy Preparation		Evening Before Colonoscopy Preparation		Same Day Prep Colonoscopy Preparation
Arm/Group Description	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.		Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.		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.
All Cause Mortality
	Split Dose Colonoscopy Preparation		Evening Before Colonoscopy Preparation		Same Day Prep Colonoscopy Preparation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Split Dose Colonoscopy Preparation		Evening Before Colonoscopy Preparation		Same Day Prep Colonoscopy Preparation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/187 (0%)		0/241 (0%)
Other (Not Including Serious) Adverse Events
	Split Dose Colonoscopy Preparation		Evening Before Colonoscopy Preparation		Same Day Prep Colonoscopy Preparation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/187 (0%)		0/241 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.