Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients

NCT01533688 — Not applicable, Completed, 212 participants, University of Oklahoma

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Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial

Registry	NCT01533688
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, diagnostic
Enrollment	212 (Actual)
Sponsor	University of Oklahoma (Other)
Conditions	Diabetes Mellitus
Interventions	Golytely (polyethylene glycol electrolyte lavage solution) and placebo, split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo, split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl (Drug)
Dates	start 2011-10-01, primary completion 2016-10-01, completion 2016-10-01, first posted 2012-02-15, last updated 2018-09-07
Locations	1 site in United States

-Summary

Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.

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+Arms and interventions

Arm	Type	Interventions	Description
Golytely + placebo	Active comparator	Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo	4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely Split + placebo	Placebo comparator	Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo	split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
Golytely Split + Bisacodyl	Experimental	Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl	split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg

Golytely (polyethylene glycol electrolyte lavage solution) and placebo (Drug): 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo (Drug): split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl (Drug): split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg

+Outcome measures

Primary outcomes

Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. [Day 1]: The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.

Secondary outcomes

Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. [24 hours]: Number of Participants Who Developed Side Effects of Taking Bowel Preparations

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria:

* adult diabetic outpatients referred for elective colonoscopy

Exclusion Criteria:

* patients < 18 years of age or > 75 yrs of age,
* known or suspected pregnancy,
* known or suspected renal failure,
* unstable angina,
* acute coronary syndrome,
* decompensated congestive heart failure,
* decompensated liver failure,
* known or suspected bowel obstruction,
* major psychiatric illness,
* solid organ transplant patients,
* known allergies to PEG-ELS or bisacodyl,
* prior alimentary tract surgery or refusal to consent to the study.

+Posted results

Participant flow

Milestone	Golytely + Placebo	Golytely Split + Placebo	Golytely Split + Bisacodyl
Started	71	70	71
Completed	63	60	63
Not completed	8	10	8

Outcome results

Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. (Primary), Count of participants, Participants: Golytely + Placebo 42; Golytely Split + Placebo 50; Golytely Split + Bisacodyl 47
Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. (Secondary), Count of participants, Participants: Golytely + Placebo 24; Golytely Split+Placebo 28; Golytely Split+Bisacodyl 28

Adverse events

Arm	Serious adverse events	Other adverse events
Golytely + Placebo	0/63 (0.0%)	24/63 (38.1%)
Golytely Split + Placebo	0/60 (0.0%)	27/60 (45.0%)
Golytely Split + Bisacodyl	0/63 (0.0%)	28/63 (44.4%)

Other adverse events by term

Term	Organ system	Golytely + Placebo	Golytely Split + Placebo	Golytely Split + Bisacodyl
nausea and vomiting	Gastrointestinal disorders	6/63	4/60	6/63
Bloating	Gastrointestinal disorders	10/63	10/60	10/63
Abdominal pain	Gastrointestinal disorders	2/63	4/60	2/63
Rectal burning sensation	Gastrointestinal disorders	6/63	9/60	10/63

+Locations (1)

Facility	City	Country	Status
Oklahoma VA Medical Center	Oklahoma City, Oklahoma	United States

+Investigators

Mohammad Madhoun, MD, Principal investigator, University of Oklahoma Health Science Center

My Notes

Public

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