ColonoscopyNCT06722209
Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing
A study testing polyethylene glycol (Protocol I) in people with Colonoscopy and Colonoscopy Diagnostic Techniques and Procedures, run by Eastern Mediterranean University.
Trial summary
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Colonoscopy Diagnostic Techniques and Procedures, Colonoscopy Preparation
- What is being tested?
- polyethylene glycol (Protocol I)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 10 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drinking at least 75 per cent of the solution
- Have the ability to read and understand research instructions
- Patients who agreed to participate in the study
Who cannot join
- Patients with active lower intestinal bleeding
- KKY
- Liver failure,
- Patients with end-stage acute renal failure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effect of Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing: A Randomized Controlled Trial
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
Hypotheses of the Study : Same-day administration of bowel preparation before colonoscopy; H1.1: There is a significant difference between the bowel preparation protocol with polyethylene glycol (Protocol I) and the protocol with sodium phosphate (Protocol II) in bowel preparation score scores H1.2: There is a significant difference between the compliance levels of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II) H1.3: There is a significant difference between the tolerance of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II)
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
Read the detailed description
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
This study will be conducted as a single centre prospective randomised controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private clinic in Famagusta region in patients undergoing colonoscopy.
Patients undergoing colonoscopy will be given written material about bowel preparation the day before the procedure and the protocol will be explained verbally and in writing. The bowel preparation protocol is described below.
Protocol I 06.30 Breakfast 09.00 hours: Phospho-Soda 45 ml 10.00: Phospho-Soda 45 ml At least 3 litres of liguid fluid intake until 14.00 14.30- 15.00: Colonoscopy Protocol II 06.30 Breakfast 09.00 :Polyethylene Glycol (PEG) will be diluted with 4 litres of water and one glass (200ml) will be drunk every 10 minutes until it is finished (It will be finished in about 4 hours) Colonoscopy after 2 hours Inclusion criteria
- Over 18 years of age
- Drinking at least 75 per cent of the solution
- Have the ability to read and understand research instructions
- Patients who agreed to participate in the study Sampling exclusion criteria
- Patients with active lower intestinal bleeding Patients diagnosed with CHF, liver failure, end-stage acute renal failure
A total of 118 patients were planned to be included in the study with an effect size of d=0.50, α =0.05 margin of error, 85% power, and 59 patients in each group. Considering the possibility of missing data, the sample number was increased by 10% and it was decided to take 128 patients by taking 64 patients in the groups in total.
The patients will be assigned to the experimental and control groups according to the list to be created using the randomisation program at a ratio of 1.1(https://www.random.org/). Randomisation and assignment to groups will be done by an independent researcher who is not involved in the implementation phase of the research. Thus, selection bias will be prevented in the randomization process.
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, the bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
- Conditions
- Colonoscopy, Colonoscopy Diagnostic Techniques and Procedures, Colonoscopy Preparation, Colonoscopy Preparation Outcome
- Being tested
- polyethylene glycol (Protocol I)
- Keywords
- Colonoscopy, Bowel preparation, Colorectal cancer, Patients compliance
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol (Protocol I)Other
Intestinal preparation protocol with polyethylene glycol (Protocol I)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Other | Intestinal preparation protocol with polyethylene glycol (Protocol I) Receives: Other: polyethylene glycol (Protocol I) |
| Control group | Other | Intestinal preparation protocol with with sodium phosphate content (protocol II) Receives: Other: polyethylene glycol (Protocol I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance and Tolerance to the Bowel Preparation Protocol
The Bowel Preparation Protocol Compliance and Tolerance Assessment Form will assess this primary outcome. This form assesses tolerance to the bowel preparation protocol; abdominal pain, nausea, vomiting, Abdominal distension -gas,thirst , headache, weakness and fatigue and intolerance to the solution. The rate of patients experiencing variables including Compliance and Tolerance to the Bowel Preparation Protocol will be calculated.
Measured: The patients were interviewed 30-60 dk minutes after the procedure was completed.
Secondary outcomes (1)
Bowel cleansing quality level
The effect of the bowel preparation protocol on bowel readiness will be assessed using the Boston Bowel Readiness Classification. Boston Classification of Bowel Preparation (BBPS) scores bowel cleanliness between 0 and 3 points. According to BBPS, 3 segments of the colon (left, transverse, right) are scored according to the degree of cleanliness. According to BBPS, a score of 0 indicates inadequate cleanliness and a score of 9 indicates perfect cleanliness. As the cleanliness score progresses from zero to nine, it is assessed that bowel cleanliness is approaching perfection.
Measured: BBPS will be assessed by the surgeon during colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial with experimental and control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülten Sucu Dağ, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722209
- Sponsor's protocol ID
- GSD-3
- Status last verified
- Feb 2025
- First submitted
- 29 Nov 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Theunissen F, Lantinga MA, Ter Borg PCJ, Ouwendijk RJT, Siersema PD, Bruno MJ; Trans. IT foundation study group. Efficacy of different bowel preparation regimen volumes for colorectal cancer screening and compliance with European Society of Gastrointestinal Endoscopy performance measures. United European Gastroenterol J. 2023 Jun;11(5):448-457. doi: 10.1002/ueg2.12386. Epub 2023 May 15.
PubMed 37190897
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06722209
- Acronym / sponsor ID
- GSD-3
- Conditions
- Colonoscopy, Colonoscopy Diagnostic Techniques and Procedures, Colonoscopy Preparation, Colonoscopy Preparation Outcome
- Keywords
- Colonoscopy, Bowel preparation, Colorectal cancer, Patients compliance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 9 Dec 2024 (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.
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
Hypotheses of the Study : Same-day administration of bowel preparation before colonoscopy; H1.1: There is a significant difference between the bowel preparation protocol with polyethylene glycol (Protocol I) and the protocol with sodium phosphate (Protocol II) in bowel preparation score scores H1.2: There is a significant difference between the compliance levels of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II) H1.3: There is a significant difference between the tolerance of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II)
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
Detailed description
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
This study will be conducted as a single centre prospective randomised controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private clinic in Famagusta region in patients undergoing colonoscopy.
Patients undergoing colonoscopy will be given written material about bowel preparation the day before the procedure and the protocol will be explained verbally and in writing. The bowel preparation protocol is described below.
Protocol I 06.30 Breakfast 09.00 hours: Phospho-Soda 45 ml 10.00: Phospho-Soda 45 ml At least 3 litres of liguid fluid intake until 14.00 14.30- 15.00: Colonoscopy Protocol II 06.30 Breakfast 09.00 :Polyethylene Glycol (PEG) will be diluted with 4 litres of water and one glass (200ml) will be drunk every 10 minutes until it is finished (It will be finished in about 4 hours) Colonoscopy after 2 hours Inclusion criteria
- Over 18 years of age
- Drinking at least 75 per cent of the solution
- Have the ability to read and understand research instructions
- Patients who agreed to participate in the study Sampling exclusion criteria
- Patients with active lower intestinal bleeding Patients diagnosed with CHF, liver failure, end-stage acute renal failure
A total of 118 patients were planned to be included in the study with an effect size of d=0.50, α =0.05 margin of error, 85% power, and 59 patients in each group. Considering the possibility of missing data, the sample number was increased by 10% and it was decided to take 128 patients by taking 64 patients in the groups in total.
The patients will be assigned to the experimental and control groups according to the list to be created using the randomisation program at a ratio of 1.1(https://www.random.org/). Randomisation and assignment to groups will be done by an independent researcher who is not involved in the implementation phase of the research. Thus, selection bias will be prevented in the randomization process.
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, the bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Other | Other: polyethylene glycol (Protocol I)Intestinal preparation protocol with polyethylene glycol (Protocol I) |
| Control group | Other | Other: polyethylene glycol (Protocol I)Intestinal preparation protocol with with sodium phosphate content (protocol II) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Drinking at least 75 per cent of the solution
- Have the ability to read and understand research instructions
- Patients who agreed to participate in the study
Key exclusion criteria (4 listed)
- Patients with active lower intestinal bleeding
- KKY
- Liver failure,
- Patients with end-stage acute renal failure
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 |
|---|---|---|
| polyethylene glycol (Protocol I)Intestinal preparation protocol with polyethylene glycol (Protocol I) | Other | Control group, Experimental: Intervention group |
Primary outcome
Compliance and Tolerance to the Bowel Preparation Protocol
Time frame: The patients were interviewed 30-60 dk minutes after the procedure was completed.
The Bowel Preparation Protocol Compliance and Tolerance Assessment Form will assess this primary outcome. This form assesses tolerance to the bowel preparation protocol; abdominal pain, nausea, vomiting, Abdominal distension -gas,thirst , headache, weakness and fatigue and intolerance to the solution. The rate of patients experiencing variables including Compliance and Tolerance to the Bowel Preparation Protocol will be calculated.
1 secondary outcome
Bowel cleansing quality level
Time frame: BBPS will be assessed by the surgeon during colonoscopy.
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 26 Feb 2025.
- Results publication: PubMed 37190897Theunissen F, Lantinga MA, Ter Borg PCJ, Ouwendijk RJT, Siersema PD, Bruno MJ; Trans. IT foundation study group. Efficacy of different bowel preparation regimen volumes for colorectal cancer screening and compliance with European Society of Gastrointestinal Endoscopy performance measures. United European Gastroenterol J. 2023 Jun;11(5):448-457. doi: 10.1002/ueg2.12386. Epub 2023 May 15.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing polyethylene glycol (Protocol I) in people with Colonoscopy and Colonoscopy Diagnostic Techniques and Procedures, run by Eastern Mediterranean University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 GULTEN SUCU DAĞ, Assoc Prof Dr (+905338564904, gulten.dag@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance and Tolerance to the Bowel Preparation Protocol (time frame: The patients were interviewed 30-60 dk minutes after the procedure was completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722209, which also lists 1 linked publication.
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 26 Feb 2025.