Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

Not Applicable

Completed

• Conditions: Bowel Preparation for Colonoscopy
• Interventions: Drug: placebo; Drug: lubiprostone

• Registration Number: NCT00611442
• Lead Sponsor: Brooke Army Medical Center

Brief Summary

The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-11
• Results First Submitted: 2012-07-24
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Results First Posted: 2012-11-01
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
• Ages will be from 18 years of age and older

Exclusion Criteria

• Chronic kidney disease
• Previous diagnosis of congestive heart failure
• History of bowel obstruction
• History of solid organ transplant
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	split-dose PEG solution without dietary restrictions plus placebo pretreatment
1	lubiprostone	split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment

Primary Outcome Measures

Name	Time	Method
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale	measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)	Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale	measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)	The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.
Procedure Time	measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)	Procedure time refers to the total length of time required to complete the colonoscopy
The Number of Polyps Detected on Examination	measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)	The number of colon polyps detected during the colonoscopy.

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States