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

NCT ID: NCT02643316

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-08-31

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.

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Same day 4 L preparation of PEG

Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy.

Group Type: ACTIVE_COMPARATOR

Same day 4 L preparation (Polyethylene Glycol)

Intervention Type: DRUG

Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.

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.

Group Type: ACTIVE_COMPARATOR

Split dose 4 L preparation (Polyethylene Glycol)

Intervention Type: DRUG

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.

Interventions

Same day 4 L preparation (Polyethylene Glycol)

Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

PEG bowel prep; PEG bowel prep

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Fernando Castro

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Castro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

References

Castro FJ, Al-Khairi B, Singh H, Mohameden M, Tandon K, Lopez R. Randomized Controlled Trial: Split-dose and Same-day Large Volume Bowel Preparation for Afternoon Colonoscopy Have Similar Quality of Preparation. J Clin Gastroenterol. 2019 Nov/Dec;53(10):724-730. doi: 10.1097/MCG.0000000000001213.

Reference Type: DERIVED

PMID: 31021890 (View on PubMed)

Other Identifiers

FLA 15-092

Identifier Type: -

Identifier Source: org_study_id