- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06021639
Comparison of Bowel Cleansing Regimens for Colonoscopy
February 18, 2024 updated by: Hilmi Bozkurt, Mersin University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
144
Phase
- Not Applicable
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
- Name: Hilmi Bozkurt
- Phone Number: +90 324 361 00 01
- Email: hilmibozkurt@mersin.edu.tr
Study Locations
-
-
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Mersin, Turkey, 33343
- Hilmi Bozkurt
-
Contact:
- Hilmi Bozkurt
- Phone Number: +903243610001
-
-
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
No
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients undergoing colonoscopy for colorectal cancer screening, or patients with nonspecific gastrointestinal symptoms
Exclusion Criteria:
- 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.
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
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low fiber diet group
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.
|
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.
|
No Intervention: Clear diet group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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During the colonoscopy procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hilmi Bozkurt, Mersin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hassan 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.
- 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.
- Ozer 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.
- Labianca R, Merelli B. Screening and diagnosis for colorectal cancer: present and future. Tumori. 2010 Nov-Dec;96(6):889-901.
- Haseman 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.
- Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.
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)
November 20, 2023
Primary Completion (Actual)
February 3, 2024
Study Completion (Actual)
February 18, 2024
Study Registration Dates
First Submitted
August 27, 2023
First Submitted That Met QC Criteria
August 27, 2023
First Posted (Actual)
September 1, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 18, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Mersin2023
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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