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

March 11, 2025 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Asian institute of Gastroenterology/AIG Hospitals
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

74 subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To check the large intestine
Time Frame: 60 minutes
to clear the contents in intestine like faces in gm/dl
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Manohar Dr Reddy, MBBS MD, AIG Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2024

Primary Completion (Estimated)

March 25, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bowel01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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