Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Tolerability of the preparation as assessed by a Likert-type scale
研究概览
简要总结
Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring treatment response and development of lesions. Therefore, optimal performance and visualization of mucosal lesions via adequate bowel preparation is essential in such patients. In addition, the nature of the disease and the need for multiple colonoscopies throughout a patient's lifetime makes compliance to repeated procedures difficult.
It is well known that colonoscopy preparations are generally poorly tolerated, disliked and, consequently serve as an additional burden on patients.Polyethylene glycol (PEG), despite being the golden standard, is not very well tolerated. Inadequate bowel preparations are associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly, with missed pathology. A good bowel preparation would need a solution with reasonable volume, acceptable taste, minimal diet restrictions, and easy-to-follow instructions. The strict need for adherence to drinking a relatively large volume of solution preparation may result in poor compliance.
Despite the emergence of several types of low volume preparations, the evidence on the use of such solutions remains sparse. This is especially true in terms of patients' tolerability to the solution, and its relation with adequate bowel preparation during colonoscopy.
The investigator's aim is to assess how small volume preparations such as sodium picosulfate/magnesium citrate (Citrafleet®) enhance participants tolerability to the solution, compliance, and adequacy of bowel preparations when compared to 2L polyethylene glycol + ascorbic acid (MoviPrep®) in patients with Ulcerative Colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Ulcerative Colitis
- •Patients undergoing elective outpatient colonoscopy
- •Patients consenting to the study
排除标准
- •Age less than 18 years
- •Pregnant or lactating women
- •Significant gastroparesis
- •Gastric outlet obstruction
- •Known or suspected bowel obstruction or perforation
- •Phenylketonuria
- •Toxic colitis or megacolon
- •Having a stoma
- •Compromised swallowing reflex or mental status
- •Psychiatric disease or known or suspected poor compliance
- •Severe chronic renal failure (creatinine clearance <30 mL/minute)
- •Severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
- •Dehydration
- •Laxative use or dependency
- •Chronic constipation (<3 spontaneous bm/week)
- •Uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
- •Prior colon resection
- •Age above 65 years
- •Profusely bleeding patients with severe UC
研究组 & 干预措施
Citrafleet®
Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.
干预措施: Sodium Picosulfate/Magnesium Citrate Laxative (Drug)
MoviPrep®
Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.
干预措施: 2L polyethylene glycol/ascorbic acid (Drug)
结局指标
主要结局
Tolerability of the preparation as assessed by a Likert-type scale
时间窗: 1 year
Patients will answer a data collection sheet with questions regarding their ability to tolerate the preparation without difficulty. We are using a Likert-type scale from 1 to 5, 1 being completely intolerable and 5 being very easily tolerated.
次要结局
- Quality of the preparation as assessed by the Modified Aronchick scale.(1 year)
- Quality of the preparation as assessed by the Boston Bowel Preparation Scale.(1 year)
- Assessment of adherence to protocol(1 year)
研究者
Ala'a Sharara, MD
Professor
American University of Beirut Medical Center