Comparison between 2L Coolprep® and Combination of 1L Coolprep® and bisacodyl as bowel preparation for colonoscopy

Not Applicable

Completed

Conditions: Not Applicable

Registration Number: KCT0000708

Lead Sponsor: Seoul National University Hospital

Brief Summary: BACKGROUND: Two liters of polyethylene glycol (PEG) solution administered with ascorbic acid (Asc) can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis) has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution. METHODS: This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group) or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group). The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered. RESULTS: A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96) of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10). There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01). CONCLUSIONS: Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution. TRIAL REGISTRATION: ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS) KCT0000708.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 187

Inclusion Criteria

(1)willing to consent/undergo necessary procedures
(2)between the age of 20 and 75 years
(3)healthy persons planning to have a colonoscopy

Exclusion Criteria

(1)history of abdominal surgery except appendectomy
(2)inflammatory bowel disease
(3)clinically or laboratory-confirmed ileus (both functional and mechanical)
(4)malignancy
(5)clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
(6)dementia, cognitive impairment
(7)the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
(8)known sensitivity to the agents used
(9)Pregnancy, Lactating woman

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bowel cleasing scale of whole colon

Secondary Outcome Measures

Name	Time	Method
bowel cleasing scale of Right/Transverse/Left colon;Patient' acceptance, using questionnaires;Patient's compliance, using questionnaires;Patient's satisfaction, using questionnaires