Data_Sheet_1_An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial.doc
Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI).
Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP.
Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI−7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI−3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found.
Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489).
Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03830489.
History
References
- https://doi.org//10.1016/S0140-6736(17)30396-3
- https://doi.org//10.1055/s-0032-1306690
- https://doi.org//10.1016/j.gie.2014.07.058
- https://doi.org//10.1016/j.gie.2014.09.066
- https://doi.org//10.1055/s-0043-101683
- https://doi.org//10.1016/j.cgh.2011.12.037
- https://doi.org//10.1016/j.cgh.2019.10.044
- https://doi.org//10.1038/ajg.2017.53
- https://doi.org//10.1016/j.gie.2008.05.057
- https://doi.org//10.1053/j.gastro.2005.11.061
- https://doi.org//10.1067/mge.2000.108480
- https://doi.org//10.1007/s40271-015-0154-8
- https://doi.org//10.1016/j.gie.2009.10.027
- https://doi.org//10.1055/a-0864-1942
- https://doi.org//10.1055/a-0959-0505
- https://doi.org//10.1053/j.gastro.2014.07.002
- https://doi.org//10.1016/j.gie.2014.09.048
- https://doi.org//10.1016/j.cgh.2018.12.042
- https://doi.org//10.1111/j.1365-2036.2009.04147.x
- https://doi.org//10.1055/s-0034-1391987
- https://doi.org//10.1016/j.dld.2015.06.008
Usage metrics
Read the peer-reviewed publication
Categories
- Radiology and Organ Imaging
- Foetal Development and Medicine
- Obstetrics and Gynaecology
- Medical Genetics (excl. Cancer Genetics)
- Medical and Health Sciences not elsewhere classified
- Dermatology
- Emergency Medicine
- Gastroenterology and Hepatology
- Geriatrics and Gerontology
- Intensive Care
- Primary Health Care
- Nephrology and Urology
- Nuclear Medicine
- Orthopaedics
- Otorhinolaryngology
- Pathology (excl. Oral Pathology)
- Family Care