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临床试验/NCT06874036
NCT06874036招募中不适用

Safety, Efficacy and Tolerability of Bowel Preparation and Colonoscopy in Patient With Chronic Heart Disease, Chronic Kidney Disease and Chronic Liver Disease

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
To check the large intestine

研究概览

简要总结

Consecutive eligible patients will be enrolled and written informed consent will be obtained from all participants. Routine blood investigations will be sent. Patients with chronic heart failure will be classified based on ejection fraction into 2 groups (EF </> 40%), patients with chronic kidney disease will be classified based on KDIGO classification system into grade I-V. Patients with chronic liver disease will be classified according to the child pugh scoring system into three groups (Child A, B and C). All patients will be undergo bowel preparation under supervision. The patients will be given 10 mg of bisacodyl, the night before colonoscopy. A PEG sachet (137.15 g) containing polyethylene glycol (118 g), sodium chloride (2.93 g), potassium chloride (1.484 g), sodium bicarbonate (3.370 g), and anhydrous sodium sulfate (11.36 g) will be constituted into 2 L solution and used for bowel preparation.

Patients will receive 1 L of PEG solution between 10 PM and 11 PM the day before and 1 L of PEG solution between 6 AM and 7 AM on the day of colonoscopy. Clear liquids will be allowed after the completion of the last bowel preparation until the start of the procedure. Liquid diet includes soups, fruit juices, rice kanji, or porridge in liquid consistency, and clear liquids such as coconut water and lemon juice.

After the adequacy of bowel preparation is deemed fit, the patients will be taken for colonoscopic examination. A single blinded outcome assessment will be done by the colonoscopist/endoscopist performing the procedure (adequacy of bowel preparation) and the endoscopy nurse (tolerability and compliance).

Colonoscopy will be performed using standard video colonoscopes (Olympus, Tokyo, Japan) between 11:00 AM and 1:00 PM without sedation. The colonoscopist / endoscopist will assess the adequacy of bowel preparation using the Boston Bowel Preparation Scale (BBPS). Excellent, good and poor bowel preparations will be defined by BBPS score of 9, 6 - 9 and < 6, respectively. (12-14) Blood sampling will be done before bowel preparation and after colonoscopy in all patients for measurement of baseline parameters, renal function status (Serum creatinine, serum urea), serum electrolytess (serum sodium, serum potassium, serum phosphate and serum calcium) and haematocrit.

Assessment of safety and tolerability will be performed using clinical examination and symptom questionnaire. Cardiovascular and gastrointestinal (GI) symptoms will be recorded. Cardiovascular symptoms such as dyspnea, palpitations, chest pain, will be recorded and scored using the NYHA classification system for symptom severity. Clinical examination will be carried out post-bowel preparation and post-procedure to assess for signs of fluid overload, i.e. auscultation for crepitations and measurement of JVP. GI symptoms such as nausea, abdominal pain, vomiting, dizziness, bloating, and headache will be recorded and scored on a 4-point scale: 1 = none, 2 = mild, 3 = moderate, and 4 = severe. The compliance of bowel preparation will be defined as "poor" for patients who consume less than 75% of the PEG preparation.

详细描述

Primary objective

• Safety of split dose 2 litre PEG bowel preparation in patients with underlying chronic conditions

Secondary objective

  • Adequacy of bowel preparation using Boston bowel preparation scale
  • Compliance of bowel preparation
  • Change from baseline to post-procedural JVP
  • Percentage of patients requiring hospitalization post-procedure

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult >18 years
  • Diagnosed cases of chronic heart disease, chronic kidney disease or chronic liver failure planned for elective colonoscopy

排除标准

  • Age < 18 years
  • Current or past history of bowel obstruction or resection
  • Known allergies to PEG
  • Emergency colonoscopies.
  • Pregnant or lactating women
  • Paralytic ileus / Bowel perforation
  • Inability to protect airway

结局指标

主要结局

To check the large intestine

时间窗: 60 minutes

to clear the contents in intestine like faces in gm/dl

次要结局

未报告次要终点

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Director

Asian Institute of Gastroenterology, India

研究点 (1)

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