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

NCT02264249 | Completed Results

• 1 other identifier: FLA 14-086
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagogastroduodenoscopy; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (2)

• pH of Gastric Fluid of Different Bowel Preparation Regimens

  1 day

• Procedure Complications (Decrease in Oxygen Saturation)

  1 day

Study Arms (3)

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

Evening before colonoscopy preparation

Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)

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)

Other: Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation

Interventions

Esophagogastroduodenoscopy and colonoscopy split dose prep OTHER

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)

Split dose colonoscopy preparation

Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep OTHER

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

Evening before colonoscopy preparation

Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation OTHER

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

Same day prep colonoscopy preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined Esophagogastroduodenoscopy and colonoscopy procedures at Cleveland Clinic Florida.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and 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.

Results Point of Contact

• Title: Dr. Alison Schneider
• Organization: Cleveland Clinic Florida

schneia2@ccf.org

954-659-5646

Study Officials

• Alison Schneider, M.D.

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 17, 2017
• Results First Posted: September 9, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)