Colon DiseaseNCT06874036
Safety, Efficacy and Tolerability of Bowel Preparation and Colonoscopy in Patient With CHD, CKD and CLD
An observational study of Colon Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Disease
- What is being tested?
- Colonoscopy
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 10 Aug 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 74 subjects
Who may be able to join
- Adult >18 years
- Diagnosed cases of chronic heart disease, chronic kidney disease or chronic liver failure planned for elective colonoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500082
Dr Mohan Ramchandani, MBBS MD DM, 04023378888 ext. 802, ramchandanimohan@gmail.com
Dr SHASHEENDRA YANAGANDULA, MBBS MS, 9676050769, shasheendra8@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Colonoscopy
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic test
Colonoscopy is a procedure to see the ascending, transverse, decending, sigmoid, rectum of colon parts
What is being measured
The primary outcome is the main question the study is designed to answer.
To check the large intestine
to clear the contents in intestine like faces in gm/dl
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Aug 2024
- Primary completion25 Mar 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseaseStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Manohar Dr Reddy, MBBS MD, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874036
- Sponsor's protocol ID
- Bowel01
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Tolerability of Bowel Preparation and Colonoscopy in Patient With Chronic Heart Disease, Chronic Kidney Disease and Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT06874036
- Acronym / sponsor ID
- Bowel01
- Conditions
- Colon Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 74 subjects
Key inclusion criteria (2 listed)
- Adult >18 years
- Diagnosed cases of chronic heart disease, chronic kidney disease or chronic liver failure planned for elective colonoscopy
Key exclusion criteria (7 listed)
- Age < 18 years
- Current or past history of bowel obstruction or resection
- Known allergies to PEG
- Emergency colonoscopies.
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyColonoscopy is a procedure to see the ascending, transverse, decending, sigmoid, rectum of colon parts | Diagnostic test | – |
Primary outcome
To check the large intestine
Time frame: 60 minutes
to clear the contents in intestine like faces in gm/dl
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manohar Dr Reddy, MBBS MD principal investigator
AIG Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Goud Mr Maragoni, M.Pharm, MBA (04023378888 ext. 531, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To check the large intestine (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.