Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing

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®).

Timeline

Start

2020-11-06

Primary completion

2024-04-01

Completion

2024-04-01

Drugs

Indications