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

NCT ID: NCT06874036

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2025-05-30

Brief 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.

Detailed Description

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

Conditions

Colon Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Colonoscopy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Mohan Ramchandani

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manohar Dr Reddy, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

AIG Hospitals

Locations

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Rajesh Goud Mr Maragoni, M.Pharm, MBA

Role: CONTACT

rajeshgoud761@gmail.com

04023378888 ext. 531

Siddhant Dr Agarwal, MBBS MD

Role: CONTACT

siddhantagrawal625@gmail.com

04023378888 ext. 101

Facility Contacts

Dr Mohan Ramchandani, MBBS MD DM

Role: primary

ramchandanimohan@gmail.com

04023378888 ext. 802

Dr SHASHEENDRA YANAGANDULA, MBBS MS

Role: backup

shasheendra8@gmail.com

9676050769

Other Identifiers

Bowel01

Identifier Type: -

Identifier Source: org_study_id