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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Bowel Preparation for Colonoscopy

NCT number NCT01929590
Study type Interventional
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact
Status Completed
Phase Phase 3
Start date October 2011
Completion date June 2012

See also
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Recruiting NCT01028573 - A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy N/A
Completed NCT05291325 - Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy N/A
Not yet recruiting NCT01853709 - Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients Phase 4
Completed NCT01415687 - Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose Phase 3
Completed NCT05465889 - Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy Phase 3
Completed NCT03055689 - Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study) N/A
Completed NCT02376465 - A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy Phase 2
Completed NCT01765491 - Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients N/A