Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Status:
Recruiting
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
Summary
Background:
Colorectal cancer is the most frequent neoplasm and the second cause of cancer death in
Spain. Colon cleansing is critical for visualization of lesions at colonoscopy. High-quality
cleansing allows for correct detection and resection of all lesions and may contribute to
adequate risk stratification and follow-up interval.
Low-volume laxatives improve tolerance of the colonoscopy preparation without reducing its
effectiveness. Currently, the most widely used low-volume laxatives are one liter of
Polyethylene glycol + ascorbate (PEG1A) and sodium picosulfate + magnesium citrate (PSCM).
The evidence on the comparison of laxatives to achieve a high-quality colonic cleansing is
very scarce.
Hypothesis:
Polyethylene glycol 1 liter with ascorbate is superior to sodium picosulfate and magnesium
citrate in high-quality colon cleansing.
Objective:
Overall objective:
To compare the global high-quality cleansing frequency between the two laxatives using the
Harefield Scale (HS).
The primary objective is to demonstrate non-inferiority in global high-quality cleansing of
PEG1A compared to PSCM. If non-inferiority is demonstrated, superiority of PEG1A will be
analyzed.
Specific objectives:
- Frequency of global high-quality cleansing using the Boston Bowel Preparation Scale
(BBPS).
- Frequency of adequate-quality cleansing using the HS and BBPS scales.
- Tolerance and adverse effects of both laxatives.
- Detection of lesions, total adenomas, advanced adenomas, total serrated lesions,
advanced serrated lesions and colorectal cancer.
- Detection of neoplastic lesions in the different colon segments (proximal, transverse,
descending, sigmoid and rectum).
- Association between detected lesions and the quality of the preparation, according to
the HS and BBPS scales.
Methods:
Phase 4, multi-centric, randomized, single-blind (endoscopist), parallel study with two
treatment arms: PEG1A (Pleinvue®) and PSCM (Citrafleet®).