Morning-Only 4 L PEG vs Split Dose Prep for Afternoon Colonoscopies, Endoscopist-Blinded Prospective Study

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02643316
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Drug: Same day 4 L preparation (Polyethylene Glycol); Drug: Split dose 4 L preparation (Polyethylene Glycol)	N/A

Detailed Description

The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.

Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Same day 4 L preparation of PEG Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy.	Drug: Same day 4 L preparation (Polyethylene Glycol); Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.; Other Names: PEG bowel prep
Active Comparator: Split dose 4 L preparation of of the PEG Receive the split-dose regimen. Will take half (2 L) of the PEG preparation the evening before colonoscopy and half (2 L) of the PEG preparation on the morning of the procedure.	Drug: Split dose 4 L preparation (Polyethylene Glycol); Receive the split-dose regimen. Will take half (2 L) the preparation the evening before colonoscopy and half (2 L) on the morning of the procedure.; Other Names: PEG bowel prep

Outcome Measures

Primary Outcome Measures

1. Quality of preparation (Ottawa score) [During the colonoscopy]

   The quality of bowel preparation will be assessed for the 2 groups at the time of the colonoscopy using the Ottawa score for quality of preparation.

Secondary Outcome Measures

1. Patient satisfaction with the bowel preparation (questionnaire). [Before the colonoscopy procedure.]

   Patient satisfaction with the bowel preparation in the 2 groups will be assessed using an approved questionnaire at the time of pre-operative assessment of the patient.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. All patients above 18 years of age undergoing elective outpatient colonoscopy at CCF Florida who are scheduled for an afternoon colonoscopy procedure. All patients must have been prescribed a 4 L PEG based bowel preparation.

Exclusion Criteria:

1. Patients who had prior Colectomy or colon resection surgery.

2. Patients with confirmed diagnosis of impaired GI motility.

3. Chronic nausea or vomiting.

4. Severe constipation (=/<1 bowel movement per week).

5. Pregnancy.

6. Breast feeding.

7. Patients taking drugs which are known to influence GI motility.

8. Hospital inpatients.

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: Fernando Castro, M.D., Cleveland Clinic Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fernando Castro, Staff Physician, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02643316
• Other Study ID Numbers: FLA 15-092
• First Posted: Dec 31, 2015
• Last Update Posted: Dec 4, 2019
• Last Verified: Dec 1, 2019

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

Study Results

No Results Posted as of Dec 4, 2019