Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06874036

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

Led by Asian Institute of Gastroenterology, India · Updated on 2025-03-13

74

Participants Needed

1

Research Sites

9 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and tolerability of a split-dose 2-liter polyethylene glycol (PEG) bowel preparation in adults with chronic heart disease, chronic kidney disease, or chronic liver disease who are scheduled for elective colonoscopy. The study also aims to assess bowel preparation quality using the Boston Bowel Preparation Scale, patient compliance with the preparation, changes in jugular venous pressure after the procedure, and hospitalization rates post-colonoscopy. This observational research is led by the Asian Institute of Gastroenterology, India. Participants will undergo bowel preparation with a split dose of PEG solution: 1 liter taken between 10 PM and 11 PM the night before colonoscopy, and another 1 liter between 6 AM and 7 AM on the day of the procedure. The bowel prep includes 10 mg of bisacodyl given the night before. Colonoscopy will be performed without sedation between 11 AM and 1 PM using standard video colonoscopes. Patients will be classified based on heart, kidney, or liver disease severity using established clinical scoring systems. Assessments during the study include evaluation of bowel preparation adequacy, tolerability, and compliance. During participation, patients will have routine blood tests before bowel preparation and after colonoscopy to monitor kidney function, electrolytes, and hematocrit. Clinical examinations and symptom questionnaires will record cardiovascular and gastrointestinal symptoms before and after bowel prep and procedure. Compliance will be measured based on the amount of PEG solution consumed. The main outcome is the quality of bowel cleansing measured by the Boston Bowel Preparation Scale. The study will also monitor safety through symptom scoring and clinical signs of fluid overload. Total participation includes preparation, procedure, and post-procedure assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults older than 18 years
  • Diagnosed cases of chronic heart disease, chronic kidney disease, or chronic liver failure
  • Planned for elective colonoscopy
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Current or past history of bowel obstruction or bowel resection
  • Known allergies to polyethylene glycol (PEG)
  • Emergency colonoscopies
  • Pregnant or lactating women
  • Paralytic ileus or bowel perforation
  • Inability to protect airway

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo colonoscopy to examine parts of the large intestine.

1 visit (in-person)

Surveillance

Duration - Up to several weeks after the procedure

Participants are observed for safety and outcomes after the colonoscopy procedure.

1 to 2 visits depending on clinical need

Trial Site Locations

Total: 1 location

1

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, India, 500082

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Research Team

R

Rajesh Goud Mr Maragoni, M.Pharm, MBA

S

Siddhant Dr Agarwal, MBBS MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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