Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study
2
조회
0
다운로드
7
인용
0
참고문헌
키워드
초록
Background/Aims: The use of a low-volume bowel cleansing agent is associated with a greater willingness to undergo repeat colonoscopy. Oral sulfate solution (OSS) is a recently approved low-volume agent; however, its efficacy and safety in the elderly population remain unclear. We aimed to evaluate the efficacy, safety, and acceptability of the OSS preparation, in comparison to those of a standard polyethylene glycol (PEG; 4 L) preparation, in elderly patients. Methods: A multicenter, randomized, investigator-blinded study was conducted. Participants were randomized to receive OSS or 4-L PEG with a split-dose regimen. Bowel cleansing efficacy was assessed using the Boston Bowel Preparation Scale (BBPS). Acceptance, satisfaction, and preparation-related symptoms were recorded. Additionally, blood parameters were analyzed for electrolyte abnormalities and nephrotoxicity. Results: A total of 193 patients were analyzed. No group differences in overall bowel cleansing efficacy were observed, with “adequate” preparations achieved in 95.9% (93/97) and 94.8% (91/96) of patients in the OSS and 4L PEG groups, respectively (p=0.747). However, mean BBPS scores for the entire (p=0.010) and right colon (p=0.001) were significantly higher in the OSS group than in the 4-L PEG group. The severity of clinical adverse events and frequency of acute kidney injury were similarly low, and no clinically meaningful electrolyte changes were identified. Self-reported scores regarding amount (p<0.001) and feeling (p=0.007), as well as overall satisfaction (p=0.001) and willingness to repeat the preparation (92.8% vs 67.7%, p<0.001), were significantly better in the OSS group than in the 4-L PEG group. Conclusions: In elderly individuals, OSS with a split-dose regimen has greater acceptability and comparable efficacy in bowel cleansing compared to 4-L PEG. (Clinical trials registration number: NCT03112967)
Abstract
Background/Aims: The use of a low-volume bowel cleansing agent is associated with a greater willingness to undergo repeat colonoscopy. Oral sulfate solution (OSS) is a recently approved low-volume agent; however, its efficacy and safety in the elderly population remain unclear. We aimed to evaluate the efficacy, safety, and acceptability of the OSS preparation, in comparison to those of a standard polyethylene glycol (PEG; 4 L) preparation, in elderly patients. Methods: A multicenter, randomized, investigator-blinded study was conducted. Participants were randomized to receive OSS or 4-L PEG with a split-dose regimen. Bowel cleansing efficacy was assessed using the Boston Bowel Preparation Scale (BBPS). Acceptance, satisfaction, and preparation-related symptoms were recorded. Additionally, blood parameters were analyzed for electrolyte abnormalities and nephrotoxicity. Results: A total of 193 patients were analyzed. No group differences in overall bowel cleansing efficacy were observed, with “adequate” preparations achieved in 95.9% (93/97) and 94.8% (91/96) of patients in the OSS and 4L PEG groups, respectively (p=0.747). However, mean BBPS scores for the entire (p=0.010) and right colon (p=0.001) were significantly higher in the OSS group than in the 4-L PEG group. The severity of clinical adverse events and frequency of acute kidney injury were similarly low, and no clinically meaningful electrolyte changes were identified. Self-reported scores regarding amount (p<0.001) and feeling (p=0.007), as well as overall satisfaction (p=0.001) and willingness to repeat the preparation (92.8% vs 67.7%, p<0.001), were significantly better in the OSS group than in the 4-L PEG group. Conclusions: In elderly individuals, OSS with a split-dose regimen has greater acceptability and comparable efficacy in bowel cleansing compared to 4-L PEG. (Clinical trials registration number: NCT03112967)
참고문헌 (37)
- Rabeneck L, "Outcomes of colorectal cancer in the United States : no change in survival(1986-1997)", Am J Gastroenterol, 98, pp.471~477 (2003)
- Jemal A, "Cancer statistics, 2010", CA Cancer J Clin, 60, pp.277~300 (2010)
- Doubeni CA, "Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer : a large community-based study", Gut, 67, pp.291~298 (2018)
- Nishihara R, "Long-term colorectal-cancer incidence and mortality after lower endoscopy", N Engl J Med, 369, pp.1095~1105 (2013)
- Lieberman DA, "Guidelines for colonoscopy surveillance after screening and polypectomy : a consensus update by the US Multi-Society Task Force on Colorectal Cancer", Gastroenterology, 143, pp.844~857 (2012)
- "Am J Gastroenterol", 2009, 739~750
- Di Palma JA, "A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy", Am J Gastroenterol, 104, pp.2275~2284 (2009)
- Rex DK, "A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy", Gastrointest Endosc, 72, pp.328~336 (2010)
- Katz PO, "A dual-action, low-volume bowel cleanser administered the day before colonoscopy : results from the SEE CLEAR II study", Am J Gastroenterol, 108, pp.401~409 (2013)
- Rex DK, "Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy : the SEE CLEAR I study", Gastrointest Endosc, 78, pp.132~141 (2013)
- Karajeh MA, "Colonoscopy in elderly people is a safe procedure with a high diagnostic yield : a prospective comparative study of 2000 patients", Endoscopy, 38, pp.226~230 (2006)
- Ma WT, "Colonoscopy in elderly Asians : a prospective evaluation in routine clinical practice", J Dig Dis, 8, pp.77~81 (2007)
- Lukens FJ, "Colonoscopy in octogenarians : a prospective outpatient study", Am J Gastroenterol, 97, pp.1722~1725 (2002)
- Bat L, "Colonoscopy in patients aged 80 years or older and its contribution to the evaluation of rectal bleeding", Postgrad Med J, 68, pp.355~358 (1992)
- Burtin P, "Colonic investigations in the elderly:colonoscopy or barium enema?", Aging (Milano), 7, pp.190~194 (1995)
- Chatrenet P, "Colonoscopy in the elderly : a study of 200 cases", Eur J Med, 2, pp.411~413 (1993)
- Schmilovitz-Weiss H, "Predictors of failed colonoscopy in nonagenarians : a single-center experience", J Clin Gastroenterol, 41, pp.388~393 (2007)
- Duncan JE, "Colonoscopy in the elderly : low risk, low yield in asymptomatic patients", Dis Colon Rectum, 49, pp.646~651 (2006)
- Syn WK, "Colonoscopy in the very elderly is safe and worthwhile", Age Ageing, 34, pp.510~513 (2005)
- DiPalma JA, "Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing", Am J Gastroenterol, 98, pp.2187~2191 (2003)
- Ell C, "Randomized trial of lowvolume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy", Am J Gastroenterol, 103, pp.883~893 (2008)
- Brunelli SM, "Risk of kidney injury following oral phosphosoda bowel preparations", J Am Soc Nephrol, 18, pp.3199~3205 (2007)
- Lai EJ, "The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research", Gastrointest Endosc, 69(3 Pt 2), pp.620~625 (2009)
- Schanz S, "Bowel preparation for colonoscopy with sodium phosphate solution versus polyethylene glycol-based lavage : a multicenter trial", Diagn Ther Endosc, 2008, pp.713521~ (2008)
- Kojecky V, "A single or split dose picosulphate", magnesium citrate before colonoscopy: comparison regarding tolerance and efficacy with polyethylene glycol. A randomized trial, 2014, pp.23, 141~146
- Chung YW, "Patient factors predictive of inadequate bowel preparation using polyethylene glycol : a prospective study in Korea", J Clin Gastroenterol, 43, pp.448~452 (2009)
- 차재명, "Would You Recommend Screening Colonoscopy for the Very Elderly?", Intestinal research, 12(4), pp.275~280 (2014), 대한장연구학회
- Cha JM, "Risks and benefits of colonoscopy in patients 90 years or older, compared with younger patients", Clin Gastroenterol Hepatol, 14, pp.80~86 (2016)
- Loffeld RJ, "Yearly diagnostic yield of colonoscopy in patients age 80 years or older, with a special interest in colorectal cancer", Geriatr Gerontol Int, 12, pp.298~303 (2012)
- Day LW, "Adverse events in older patients undergoing colonoscopy : a systematic review and meta-analysis", Gastrointest Endosc, 74, pp.885~896 (2011)
- Patel SS, "Elderly patients with colon cancer have unique tumor characteristics and poor survival", Cancer, 119, pp.739~747 (2013)
- Holt PR, "Colon cancer and the elderly : from screening to treatment in management of GI disease in the elderly", Best Pract Res Clin Gastroenterol, 23, pp.889~907 (2009)
- Berkelhammer C, "Low-volume oral colonoscopy bowel preparation : sodium phosphate and magnesium citrate", Gastrointest Endosc, 56, pp.89~94 (2002)
- Corporaal S, "Low-volume PEG plus ascorbic acid versus high-volume PEG as bowel preparation for colonoscopy", Scand J Gastroenterol, 45, pp.1380~1386 (2010)
- Pelham RW, "Safety of oral sulfates in rats and dogs contrasted with phosphateinduced nephropathy in rats", Int J Toxicol, 28, pp.99~112 (2009)
- Patel V, "Intestinal and renal effects of low-volume phosphate and sulfate cathartic solutions designed for cleansing the colon : pathophysiological studies in five normal subjects", Am J Gastroenterol, 104, pp.953~965 (2009)
- Calderwood AH, "Comprehensive validation of the Boston Bowel Preparation Scale", Gastrointest Endosc, 72, pp.686~692 (2010)