Colonoscopy PreparationNCT06021639
Comparison of Bowel Cleansing Regimens for Colonoscopy
A study testing The last 24 hours will consume low fiber food. in people with Colonoscopy Preparation, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel cleansing is performed for colonoscopy. When the guidelines are examined, there are various recommendations regarding colonoscopy preparation regimens and durations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- The last 24 hours will consume low fiber food.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 18 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients aged 18 years and older
- Patients undergoing colonoscopy for colorectal cancer screening, or patients with nonspecific gastrointestinal symptoms
Who cannot join
- Patients with a serious medical condition such as severe heart
- Kidney or metabolic disease
- Psychiatric disease not complying with the recommended regimen
- Patients with a history of colon resection for any reason
- Patients with suspected intestinal obstruction or ileus
- Patients undergoing emergency colonoscopy
- Patients who did not accept the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 1-day Clear Liquid Diet and Low-fiber Diet in Bowel Preparation for Colonoscopy
Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel cleansing is performed for colonoscopy. When the guidelines are examined, there are various recommendations regarding colonoscopy preparation regimens and durations. In this study, participants using the same colon cleansing drug before colonoscopy will be compared in terms of colon cleansing of the patient group who had a clear diet in the last 24 hours before the procedure and the patient group who had a low fiber diet.
Read the detailed description
Studies have reported that inadequate bowel preparation reduces the detection of polyps that may have the potential to become cancerous. Unfortunately, however, many participants are unable to comply with bowel cleansing regimens due to strict dietary changes and large amounts of unpleasant laxative solutions that affect their quality of life before the procedure. In addition, participants with insufficient bowel cleansing should repeat similar preparation steps before the next examination. The European Society for Gastrointestinal Endoscopy (ESGE) recommends a polyethylene glycol (PEG) regimen for colonoscopy preparation and low-fiber food intake 24 hours prior to the procedure. In our country, PEG is not used routinely and frequently in terms of cost and lack of SGK payments. 'Sennoside A+B calcium', which is used for colonoscopy preparation in our country, shows its effect by increasing intestinal motility and causes the accumulation of water and electrolytes in the colon lumen. It has security and ease of application. In addition, the fact that it is paid by the Social Security Institution and the price is affordable makes it advantageous in the preparation of colonoscopy. Although there is not enough data for colonoscopy preparation in our country, each clinic determines the duration of the regimen in various ways. The aim of this study is to compare the patient group who used low fiber food for 24 hours before colonoscopy and who had a clear diet for 24 hours before colonoscopy in terms of adequate cleaning during endoscopy in participants who underwent bowel cleansing with 'Sennoside A+B calcium'.
- Conditions
- Colonoscopy Preparation
- Being tested
- The last 24 hours will consume low fiber food.
- Keywords
- Bowel preparation, Colonoscopy, Sennoside A+B calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The last 24 hours will consume low fiber food.Dietary supplement
White bread, white rice, plain pasta or noodles, cereals not containing more than 1 gram of fiber per serving., canned or cooked skinless and seedless fruit, skinless and seedless raw fruit, pulp-free or low-fiber fruit or vegetable broth, seedless, seedless, skinless, such as canned or well-cooked carrots, string beans or peppers vegetables, tender red meat, poultry and fish, eggs, no more than two tablespoons per day, soft (creamy) peanut butter, milk, yogurt or plain cheese, salad dressings without oils or nuts, desserts without nuts.
| Study group | Role | What they receive |
|---|---|---|
| Low fiber diet group | Experimental | 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours. Receives: Dietary Supplement: The last 24 hours will consume low fiber food. |
| Clear diet group | No intervention | 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleaning during colonoscopy
The quality of cleaning for each segment of the colon was rated ac- cording to the Boston Bowel Preparation Scale (BBPS) as follows: Score 0 (mucosa not visible due to solid stool, or thick liquid stool cannot be cleared); Score 1 (areas of the colon segment not seen well due to staining, resid- ual stool, and/or opaque liquid); Score 2 (minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa seen well); and Score 3 (en- tire mucosa of the colon segment seen well). The left colon, transverse colon, and right colon segments were scored separately, and then these segment scores were summed for a total BBPS score ranging from 0 to 9. Categorical assessment for each possible total BBPS score: "excellent," 8-9; "good," 6-7; "fair," 5; "poor," 3-4; or "unsatisfactory," 0-2
Measured: During the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start20 Nov 2023
- Primary completion3 Feb 2024
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy PreparationStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clear diet group (72 patients) 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet. Low fiber diet group (72 patients) 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilmi Bozkurt, Mersin University
- Investigators
- Hilmi Bozkurt, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021639
- Sponsor's protocol ID
- Mersin2023
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lorenzo-Zuniga V, Moreno-de-Vega V, Boix J. [Preparation for colonoscopy: types of scales and cleaning products]. Rev Esp Enferm Dig. 2012 Aug;104(8):426-31. doi: 10.4321/s1130-01082012000800006. Spanish.
PubMed 23039803Ozer Etik D, Suna N, Gunduz C, Bostan A, Ozdemir A, Gurel BY, Yenisekerci E, Boyacioglu AS. Can a 1-day clear liquid diet with a split -dose polyethylene glycol overcome conventional practice patterns during the preparation for screening colonoscopy? Turk J Gastroenterol. 2019 Sep;30(9):817-825. doi: 10.5152/tjg.2019.19071.
PubMed 31258137Labianca R, Merelli B. Screening and diagnosis for colorectal cancer: present and future. Tumori. 2010 Nov-Dec;96(6):889-901.
PubMed 21388049Haseman JH, Lemmel GT, Rahmani EY, Rex DK. Failure of colonoscopy to detect colorectal cancer: evaluation of 47 cases in 20 hospitals. Gastrointest Endosc. 1997 Jun;45(6):451-5. doi: 10.1016/s0016-5107(97)70172-x.
PubMed 9199899Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.
PubMed 22104756
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 1-day Clear Liquid Diet and Low-fiber Diet in Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT06021639
- Acronym / sponsor ID
- Mersin2023
- Conditions
- Colonoscopy Preparation
- Keywords
- Bowel preparation, Colonoscopy, Sennoside A+B calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 1 Sep 2023 (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.
Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel cleansing is performed for colonoscopy. When the guidelines are examined, there are various recommendations regarding colonoscopy preparation regimens and durations. In this study, participants using the same colon cleansing drug before colonoscopy will be compared in terms of colon cleansing of the patient group who had a clear diet in the last 24 hours before the procedure and the patient group who had a low fiber diet.
Detailed description
Studies have reported that inadequate bowel preparation reduces the detection of polyps that may have the potential to become cancerous. Unfortunately, however, many participants are unable to comply with bowel cleansing regimens due to strict dietary changes and large amounts of unpleasant laxative solutions that affect their quality of life before the procedure. In addition, participants with insufficient bowel cleansing should repeat similar preparation steps before the next examination. The European Society for Gastrointestinal Endoscopy (ESGE) recommends a polyethylene glycol (PEG) regimen for colonoscopy preparation and low-fiber food intake 24 hours prior to the procedure. In our country, PEG is not used routinely and frequently in terms of cost and lack of SGK payments. 'Sennoside A+B calcium', which is used for colonoscopy preparation in our country, shows its effect by increasing intestinal motility and causes the accumulation of water and electrolytes in the colon lumen. It has security and ease of application. In addition, the fact that it is paid by the Social Security Institution and the price is affordable makes it advantageous in the preparation of colonoscopy. Although there is not enough data for colonoscopy preparation in our country, each clinic determines the duration of the regimen in various ways. The aim of this study is to compare the patient group who used low fiber food for 24 hours before colonoscopy and who had a clear diet for 24 hours before colonoscopy in terms of adequate cleaning during endoscopy in participants who underwent bowel cleansing with 'Sennoside A+B calcium'.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Clear diet group (72 patients) 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet. Low fiber diet group (72 patients) 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours.
| Arm | Type | Receives |
|---|---|---|
| Low fiber diet group | Experimental | Dietary Supplement: The last 24 hours will consume low fiber food.250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours. |
| Clear diet group | No intervention | –250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 18 years and older
- Patients undergoing colonoscopy for colorectal cancer screening, or patients with nonspecific gastrointestinal symptoms
Key exclusion criteria (7 listed)
- Patients with a serious medical condition such as severe heart
- Kidney or metabolic disease
- Psychiatric disease not complying with the recommended regimen
- Patients with a history of colon resection for any reason
- Patients with suspected intestinal obstruction or ileus
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 |
|---|---|---|
| The last 24 hours will consume low fiber food.White bread, white rice, plain pasta or noodles, cereals not containing more than 1 gram of fiber per serving., canned or cooked skinless and seedless fruit, skinless and seedless raw fruit, pulp-free or low-fiber fruit or vegetable broth, seedless, seedless, skinless, such as canned or well-cooked carrots, string beans or peppers vegetables, tender red meat, poultry and fish, eggs, no more than two tablespoons per day, soft (creamy) peanut butter, milk, yogurt or plain cheese, salad dressings without oils or nuts, desserts without nuts. | Dietary supplement | Low fiber diet group |
Primary outcome
Cleaning during colonoscopy
Time frame: During the colonoscopy procedure
The quality of cleaning for each segment of the colon was rated ac- cording to the Boston Bowel Preparation Scale (BBPS) as follows: Score 0 (mucosa not visible due to solid stool, or thick liquid stool cannot be cleared); Score 1 (areas of the colon segment not seen well due to staining, resid- ual stool, and/or opaque liquid); Score 2 (minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa seen well); and Score 3 (en- tire mucosa of the colon segment seen well). The left colon, transverse colon, and right colon segments were scored separately, and then these segment scores were summed for a total BBPS score ranging from 0 to 9. Categorical assessment for each possible total BBPS score: "excellent," 8-9; "good," 6-7; "fair," 5; "poor," 3-4; or "unsatisfactory," 0-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 23039803Lorenzo-Zuniga V, Moreno-de-Vega V, Boix J. [Preparation for colonoscopy: types of scales and cleaning products]. Rev Esp Enferm Dig. 2012 Aug;104(8):426-31. doi: 10.4321/s1130-01082012000800006. Spanish.
- Background: PubMed 31258137Ozer Etik D, Suna N, Gunduz C, Bostan A, Ozdemir A, Gurel BY, Yenisekerci E, Boyacioglu AS. Can a 1-day clear liquid diet with a split -dose polyethylene glycol overcome conventional practice patterns during the preparation for screening colonoscopy? Turk J Gastroenterol. 2019 Sep;30(9):817-825. doi: 10.5152/tjg.2019.19071.
- Background: PubMed 21388049Labianca R, Merelli B. Screening and diagnosis for colorectal cancer: present and future. Tumori. 2010 Nov-Dec;96(6):889-901.
- Background: PubMed 9199899Haseman JH, Lemmel GT, Rahmani EY, Rex DK. Failure of colonoscopy to detect colorectal cancer: evaluation of 47 cases in 20 hospitals. Gastrointest Endosc. 1997 Jun;45(6):451-5. doi: 10.1016/s0016-5107(97)70172-x.
- Background: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Background: PubMed 22104756Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.
Related trials for Colonoscopy Preparation
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
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. This study is not recruiting at the moment.
Hilmi Bozkurt principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The last 24 hours will consume low fiber food. in people with Colonoscopy Preparation, run by Mersin University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 20 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleaning during colonoscopy (time frame: During the colonoscopy procedure). 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 NCT06021639, which also lists 6 linked publications.
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 20 Feb 2024.