EsophagogastroduodenoscopyNCT02264249
Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation
An observational study of Esophagogastroduodenoscopy and Colonoscopy, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophagogastroduodenoscopy, Colonoscopy
- What is being tested?
- Esophagogastroduodenoscopy and colonoscopy split dose prep, Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep and Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation
- How many people
- 449 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined Esophagogastroduodenoscopy and colonoscopy procedures at Cleveland Clinic Florida.
Who may be able to join
- 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.
Who cannot join
- Upper GI or lower GI bleeding at the time of procedure
- Large amounts of vomiting reported before the procedure (with bowel preparation)
- Hospital inpatients
- History of abdominal surgery
- History of gastroparesis or other documented GI transit disorder (ex. Colonic inertia)
- Pregnancy Patients with diabetes mellitus taking Metoclopramide without proven gastroparesis by formal testing will not be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation: A Prospective Observational Study
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.
Read the 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.
- Conditions
- Esophagogastroduodenoscopy, Colonoscopy
- Being tested
- Esophagogastroduodenoscopy and colonoscopy split dose prep, Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep, Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagogastroduodenoscopy and colonoscopy split dose prepOther
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)
Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prepOther
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 preparationOther
Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation)
| Study group | Role | What they receive |
|---|---|---|
| Split dose colonoscopy preparation | Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) Receives: Other: Esophagogastroduodenoscopy and colonoscopy split dose prep | |
| Evening before colonoscopy preparation | Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) Receives: Other: Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep | |
| Same day prep colonoscopy preparation | Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation) Receives: Other: Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Schneider, The Cleveland Clinic
- Investigators
- Alison Schneider, M.D., Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264249
- Sponsor's protocol ID
- FLA 14-086
- Status last verified
- Apr 2017
- First submitted
- 6 Oct 2014
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02264249
- Acronym / sponsor ID
- FLA 14-086
- Conditions
- Esophagogastroduodenoscopy, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Posted 9 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Split dose colonoscopy preparation | – | Other: Esophagogastroduodenoscopy and colonoscopy split dose prepEsophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation) |
| Evening before colonoscopy preparation | – | Other: Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prepEsophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation) |
| Same day prep colonoscopy preparation | – | Other: Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparationEsophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined Esophagogastroduodenoscopy and colonoscopy procedures at Cleveland Clinic Florida.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Upper GI or lower GI bleeding at the time of procedure
- Large amounts of vomiting reported before the procedure (with bowel preparation)
- Hospital inpatients
- History of abdominal surgery
- History of gastroparesis or other documented GI transit disorder (ex. Colonic inertia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagogastroduodenoscopy and colonoscopy split dose prepPatients 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) | Other | Split dose colonoscopy preparation |
| Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prepPatients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation) | Other | Evening before colonoscopy preparation |
| Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparationPatients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation) | Other | Same day prep colonoscopy preparation |
Primary outcome
Residual Gastric Volumes of Different Bowel Preparation Regimens
Time frame: 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.
2 secondary outcomes
pH of Gastric Fluid of Different Bowel Preparation Regimens
Time frame: 1 day
Procedure Complications (Decrease in Oxygen Saturation)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Schneider, M.D. principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagogastroduodenoscopy and Colonoscopy, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Gastric Volumes of Different Bowel Preparation Regimens (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.