RecruitingNCT06874036

Safety, Efficacy and Tolerability of Bowel Preparation and Colonoscopy in Patient With CHD, CKD and CLD

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


Sponsor

Asian Institute of Gastroenterology, India

Enrollment

74 participants

Start Date

Aug 10, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether the standard bowel preparation used before a colonoscopy (cleaning out the colon) is safe and effective for people who also have chronic heart disease, chronic kidney disease, or chronic liver disease — conditions that can make this preparation riskier. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with chronic heart disease, chronic kidney disease, or chronic liver failure - You are scheduled for a planned (non-emergency) colonoscopy **You may NOT be eligible if...** - You are under 18 years old - You have a history of bowel blockage or have had bowel surgery - You have a known allergy to the bowel preparation medication (PEG) - Your colonoscopy is an emergency - You are pregnant or breastfeeding - You have a paralyzed bowel or bowel perforation (hole) - You cannot safely swallow and protect your airway Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTColonoscopy

Colonoscopy is a procedure to see the ascending, transverse, decending, sigmoid, rectum of colon parts


Locations(1)

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, India

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NCT06874036


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