A Safety and Efficacy Comparison of polyethylene glycol, hemp seed oil, and 5% sugar brine for bowel preparation in older adults patients: study protocol for a randomized controlled trial

Abstract

Abstract Background: The incidence of colorectal cancer among the middle-aged and elderly is gradually increasing in China. Colonoscopy is an effective method for early diagnosis of colorectal cancer, and bowel preparation is one of many important factors affecting colonoscopy. Although there are many studies on intestinal cleansers, the results are not ideal. There is evidence that hemp seed oil has certain potential effects in intestinal cleansing, but prospective studies in this area are still lacking. Methods: This is a randomized, double-blind, single-center clinical study. We randomly assigned 690 subjects to a combination of 3L PEG; 30 mL hemp seed oil and 2L PEG; or 30 mL hempseed oil, 2L PEG, and 1000 ml 5% sugar brine. Boston Bowel Preparation Scale (BBPS) was considered the primary outcome measure. We evaluated the interval between consumption of the bowel preparation and the first bowel movement. Secondary indicators were evaluated after the total number of bowel movements; these included the time of cecal intubation, the detection rate of polyps and adenomas, the willingness to repeat the same bowel preparation, whether the protocol is tolerated, and whether there were adverse reactions during bowel preparation. Discussion: This study aimed to test the hypotheses that hemp seed oil (30 ml) increases the quality of bowel preparation while reducing the amount of polyethylene glycol (PEG), and its combination with 5% sugar saline can reduce the occurrence of adverse reactions. Trial registration: The study was prospectively registered on March 15, 2022, Chinese Clinical Trial Registry (www.chictr.org.cn, ChiCTR2200057626); Pre-results.