NCT01929590

Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

Efficacy and Tolerability of Low-volume Polyethylene Glycol (2 L) vs. Single- (4 L) vs. Split-dose (2L + 2L) of Polyethylene Glycol Bowel Preparation for Colonoscopy: a Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.

Detailed description

In-hospital patients were randomly assigned to one of three groups: group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am). The quality of colonic preparation was assessed by the Boston bowel preparation scale (13); tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and adverse effects in group 3 were compared with those in groups 1 and 2. The time since the last dose of bowel-preparation agent, the time since the last solid food was consumed, the approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of the colonoscopy were recorded. Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

Conditions

• Bowel Preparation for Colonoscopy

Interventions

Type	Name	Description
DRUG	PEG-3350 group 2	split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)
DRUG	PEG-3350 group 1	PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h
DRUG	PEG-3350 group 3	low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2013-08-28
• Last updated: 2013-08-28

Locations

1 site across 1 country: Mexico