Skip to main content
OpenTrials
Completed

NCT Number: NCT01929590

Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bowel Preparation for Colonoscopy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG-3350 group 2

Drug

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)

Other names: Nulytely

PEG-3350 group 1

Drug

PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h

Other names: Nulytely

PEG-3350 group 3

Drug

low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)

Other names: Nulytely

Primary outcomes

  1. satisfactory bowel preparation

    Time frame: 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 outcomes

  1. tolerability with bowel preparation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 28, 2013
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.