A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Efficacy of cleansing agent
研究概览
简要总结
The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease.
400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents.
The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.
详细描述
Abbreviations:
PEG: Polyethelynglycol PEG-ELS: Polyethelynglycol-electrolytes lavage solution SPMC: Sodium picosulfate/magnesium citrate L: liter ex.: example Ml: milliliter eGFR: estimated glomerular filtration rate G: gram WHO - World Health Organization CIOMS - Council of International Organizations of Medical Sciences ICH - International Conference on Harmonisation
Introduction:
- Aim of the study:
The study aims to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu® with the well-established bowel preparation Picoprep® as cleansing agents before colonoscopy. This is to test whether the low volume PEG-ELS preparation Plenvu® would have non-inferior efficacy on bowel cleansing compared with Picoprep® with a comparable effect on compliance and tolerability. 2. Background Colonoscopy is one of the most performed procedures around the world, both for diagnostic and therapeutic purposes. The number of colonoscopies in Denmark has markedly risen after the national program for colorectal cancer screening was started in 2014. Only for screening purposes, 23.532 colonoscopies were performed in 2019 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blinded trial. The colonoscopist who performs the procedure and evaluates the quality of cleansing is blinded to which preparation was used. This is achieved during randomisation of the patient where they receive a paper form prescription, thus the colonoscopist cannot check that in the electronic system.
Blinding is not done to the patients as the bias is considered small. Cleansing agents are not normally used in the general population and the effect of previous experience to evaluate the tolerability in the present time is not considered to be large.
Subjects will be well informed in the participation information and in the meeting not to reveal the type of cleansing they received to the colonoscopist.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulant colonoscopy
- •Older than18
排除标准
- •Younger than 18
- •Known with severe heart failure
- •Known with severe renal failure (eGFR<30)
- •Known for colonic stenosis
- •Pregnant or breastfeeding
- •Acute colonoscopy
- •Cancer screening program colonoscopy
- •Mentally retarded
- •Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
- •Patients with Phenylketonuria
- •Patients with Glucose-6-phosphate-dehydrogenase deficiency
- •Patients with colon or rectum resection
研究组 & 干预措施
Picoprep
Picoprep®:
Active substances: An envelope Picoprep® contains 10 mg sodium picosulfate, 3,5 g magnesium oxide, and 12 g citric acid.
Mechanism of action: Sodium picosulfate is a peristaltic agent that increases the peristalsis of the intestine. Magnesium oxide and citric acid are osmotic agents to increase water content in the bowel.
Dosage and administration: consist of 2 envelopes, the first envelope, after dissolving in 150 ml water, should be taken 10-18 hours before the colonoscopy, then at least 250mlX5 clear fluid (not only water) over the next hours before the second dose is taken. The second envelope should be taken 4-6 hours before colonoscopy followed by 250mlX3 clear fluid (not only water) over the next hours before colonoscopy. The total fluid intake is approximately 2.3 L.
干预措施: Picoprep (Drug)
Plenvu
Plenvu®:
Active substances:
Dose nr. 1
1 envelope contains 1 g potassium chloride, 100 g macrogol 3350, 2 g sodium chloride, and 9 g sodium sulfate.
Dose nr. 2 1 envelope A contains 1,2 g potassium chloride, 40 g macrogol 3350, and 3,2 g sodium chloride.
1 envelope B contains 7,54 g ascorbic acid (Vit. C) and 48,11 g sodium ascorbate.
Mechanism of action: Macrogol 3350 is an osmotic laxative. The added electrolytes are to prevent electrolyte shifting and systemic disturbances.
Dosage and administration: two separate nonidentical 500 ml doses are given. 2-day regime: dose nr.1 envelope is dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock evening before colonoscopy day. Dose nr.2 envelope A and B are dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock on the morning of colonoscopy day.
After each dose of the dissolved Plenvu®, the patient should drink at least 500ml clear fluid.
干预措施: Plenvu (Drug)
结局指标
主要结局
Efficacy of cleansing agent
时间窗: 18 hours
The primary endpoint is the efficacy of cleansing preparations measured by the quality of cleansing. This is done using the validated Harefield Cleansing Scale. The cleansing quality is measured after dividing the colon into 5 segments (Rectum, sigmoid colon, Descending colon, Transverse colon, and Ascending colon/Cecum) and each segment is scored from 0 (irremovable heavy hard stool), 1 (Semi-solid, only partially removable stools), 2 (Brown liquid/removable semi-solid stools) 3 (Clear liquid), and 4 (empty and clean), then a total grade is given. Grade A (all segments scored 3 or 4) and B (one or more segments scored 2) are considered as successful cleansing. Grade C (one or more segments scored 1) and D (one or more segments scored 0) is considered unsuccessful cleansing.
次要结局
- Tolerability to the cleansing agent(18 hours)
研究者
Hayder Mahmood Waheeb Alqaisi
Resident doctor
Aalborg University Hospital