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

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ClinicalTrials.gov Identifier: NCT02643316
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Fernando Castro, The Cleveland Clinic

December 29, 2015
December 31, 2015
August 24, 2017
December 2015
August 2018   (Final data collection date for primary outcome measure)
Quality of preparation (Ottawa score) [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT02643316 on ClinicalTrials.gov Archive Site
Patient satisfaction with the bowel preparation (questionnaire). [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Morning-Only 4 L PEG vs Split Dose Prep for Afternoon Colonoscopies, Endoscopist-Blinded Prospective Study
Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
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 Name: PEG bowel prep
  • 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 Name: PEG bowel prep
  • 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.
    Intervention: Drug: Same day 4 L preparation (Polyethylene Glycol)
  • 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.
    Intervention: Drug: Split dose 4 L preparation (Polyethylene Glycol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Same as current
August 2018
August 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02643316
FLA 15-092
No
Not Provided
Plan to Share IPD: No
Fernando Castro, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Fernando Castro, M.D. Cleveland Clinic Florida
The Cleveland Clinic
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP