Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

Phase 3

Completed

• Conditions: Bowel Preparation for Colonoscopy
• Interventions: Drug: PEG-3350 group 3; Drug: PEG-3350 group 1; Drug: PEG-3350 group 2

• Registration Number: NCT01929590
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-21
• Last Update Submitted: 2013-08-21
• Study First Posted: 2013-08-28
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• In-hospital patients with an indication for colonoscopy

Exclusion Criteria

• patients under 18 years of age
• the presence of a severe illness (cardiac, renal, or metabolic)
• major psychiatric illness
• known allergies to PEG-3350
• refusal to consent to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-3350 group 3	PEG-3350 group 3	group 3: low-volume 2 L PEG-3350 solution (same day of the procedure 06:00-08:00 am).
PEG-3350 group 1	PEG-3350 group 1	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)
PEG-3350 group 2	PEG-3350 group 2	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)

Primary Outcome Measures

Name	Time	Method
satisfactory bowel preparation	at the moment of colonoscopy	The aim of this study was to test the quality of bowel preparation 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. The quality of colonic preparation was assessed by the Boston bowel preparation scale.Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

Secondary Outcome Measures

Name	Time	Method
tolerability with bowel preparation	just before to start the colonoscopy and before any sedative be administered	tolerability of bowel preparation was measured, considering: nausea, vomiting, and abdominal pain, compliance, sleep disturbance and adverse effects.

Trial Locations

Locations (1)

Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Distrito Federal, Mexico