Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation for Colonoscopy

Treatments: Drug: PEG-3350 group 3; Drug: PEG-3350 group 1; Drug: PEG-3350 group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01929590

end-407-11-11-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups

PEG-3350 group 3

Active Comparator group

Description:

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

Treatment:

Drug: PEG-3350 group 3

PEG-3350 group 1

Active Comparator group

Description:

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)

Treatment:

Drug: PEG-3350 group 1

PEG-3350 group 2

Experimental group

Description:

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)

Treatment:

Drug: PEG-3350 group 2