Clinical trial NCT01929590: Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation for Colonoscopy
Keywords: Colonoscopy
Preparation
Polyp
Polyethylene glycol
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: satisfactory bowel preparation
timeFrame: at the moment of colonoscopy
Secondary outcomes:
measure: tolerability with bowel preparation
timeFrame: just before to start the colonoscopy and before any sedative be administered
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán
state: Distrito Federal
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Felix Téllez-Ávila, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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