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

NCT02643316 | Completed

• 1 other identifier: FLA 15-092
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Quality of preparation (Ottawa score)

  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.

  During the colonoscopy

Secondary Outcomes (1)

• Patient satisfaction with the bowel preparation (questionnaire).

  Before the colonoscopy procedure.

Study Arms (2)

Same day 4 L preparation of PEG

ACTIVE COMPARATOR

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

Drug: Same day 4 L preparation (Polyethylene Glycol)

Split dose 4 L preparation of of the PEG

ACTIVE COMPARATOR

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)

Interventions

Same day 4 L preparation (Polyethylene Glycol) DRUG

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

Also known as: PEG bowel prep

Same day 4 L preparation of PEG

Split dose 4 L preparation (Polyethylene Glycol) 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.

Also known as: PEG bowel prep

Split dose 4 L preparation of of the PEG

Eligibility Criteria

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

You may qualify if:

• \. 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.

You may not qualify if:

• Patients who had prior Colectomy or colon resection surgery.
• Patients with confirmed diagnosis of impaired GI motility.
• Chronic nausea or vomiting.
• Severe constipation (=/\<1 bowel movement per week).
• Pregnancy.
• Breast feeding.
• Patients taking drugs which are known to influence GI motility.
• Hospital inpatients.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (1)

• 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.

  PMID: 31021890 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Fernando Castro, M.D.

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)