xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021639</url>
    </required_header>
    <id_info>
      <org_study_id>Mersin2023</org_study_id>
      <nct_id>NCT06021639</nct_id>
    </id_info>
    <brief_title>Comparison of Bowel Cleansing Regimens for Colonoscopy</brief_title>
    <official_title>Comparison of 1-day Clear Liquid Diet and Low-fiber Diet in Bowel Preparation for Colonoscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mersin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mersin University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel&#xD;
        cleansing is performed for colonoscopy. When the guidelines are examined, there are various&#xD;
        recommendations regarding colonoscopy preparation regimens and durations. In this study,&#xD;
        participants using the same colon cleansing drug before colonoscopy will be compared in terms&#xD;
        of colon cleansing of the patient group who had a clear diet in the last 24 hours before the&#xD;
        procedure and the patient group who had a low fiber diet.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Studies have reported that inadequate bowel preparation reduces the detection of polyps that&#xD;
        may have the potential to become cancerous. Unfortunately, however, many participants are&#xD;
        unable to comply with bowel cleansing regimens due to strict dietary changes and large&#xD;
        amounts of unpleasant laxative solutions that affect their quality of life before the&#xD;
        procedure. In addition, participants with insufficient bowel cleansing should repeat similar&#xD;
        preparation steps before the next examination. The European Society for Gastrointestinal&#xD;
        Endoscopy (ESGE) recommends a polyethylene glycol (PEG) regimen for colonoscopy preparation&#xD;
        and low-fiber food intake 24 hours prior to the procedure. In our country, PEG is not used&#xD;
        routinely and frequently in terms of cost and lack of SGK payments. 'Sennoside A+B calcium',&#xD;
        which is used for colonoscopy preparation in our country, shows its effect by increasing&#xD;
        intestinal motility and causes the accumulation of water and electrolytes in the colon lumen.&#xD;
        It has security and ease of application. In addition, the fact that it is paid by the Social&#xD;
        Security Institution and the price is affordable makes it advantageous in the preparation of&#xD;
        colonoscopy. Although there is not enough data for colonoscopy preparation in our country,&#xD;
        each clinic determines the duration of the regimen in various ways. The aim of this study is&#xD;
        to compare the patient group who used low fiber food for 24 hours before colonoscopy and who&#xD;
        had a clear diet for 24 hours before colonoscopy in terms of adequate cleaning during&#xD;
        endoscopy in participants who underwent bowel cleansing with 'Sennoside A+B calcium'.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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.&#xD;
  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.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Randomization will be planned 1 to 1 according to the order of application. Randomization will be planned by the endoscopy nurse in the endoscopy unit and will not be known to the endoscopist who will perform the procedure.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cleaning during colonoscopy</measure>
      <time_frame>During the colonoscopy procedure</time_frame>
      <description>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: &quot;excellent,&quot; 8-9; &quot;good,&quot; 6-7; &quot;fair,&quot; 5; &quot;poor,&quot; 3-4; or &quot;unsatisfactory,&quot; 0-2</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Colonoscopy Preparation</condition>
    <arm_group>
      <arm_group_label>Low fiber diet group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Clear diet group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>The last 24 hours will consume low fiber food.</intervention_name>
      <description>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.</description>
      <arm_group_label>Low fiber diet group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients aged 18 years and older&#xD;
  &#xD;
            -  Patients undergoing colonoscopy for colorectal cancer screening, or patients with&#xD;
               nonspecific gastrointestinal symptoms&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a serious medical condition such as severe heart&#xD;
  &#xD;
            -  Kidney or metabolic disease&#xD;
  &#xD;
            -  Psychiatric disease not complying with the recommended regimen&#xD;
  &#xD;
            -  Patients with a history of colon resection for any reason&#xD;
  &#xD;
            -  Patients with suspected intestinal obstruction or ileus&#xD;
  &#xD;
            -  Patients undergoing emergency colonoscopy&#xD;
  &#xD;
            -  Patients who did not accept the informed consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hilmi Bozkurt</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mersin University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hilmi Bozkurt</last_name>
      <phone>+90 324 361 00 01</phone>
      <email>hilmibozkurt@mersin.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hilmi Bozkurt</name>
        <address>
          <city>Mersin</city>
          <zip>33343</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Hilmi Bozkurt</last_name>
        <phone>+903243610001</phone>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>23039803</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31258137</PMID>
    </reference>
    <reference>
      <citation>Labianca R, Merelli B. Screening and diagnosis for colorectal cancer: present and future. Tumori. 2010 Nov-Dec;96(6):889-901.</citation>
      <PMID>21388049</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>9199899</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>23335011</PMID>
    </reference>
    <reference>
      <citation>Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.</citation>
      <PMID>22104756</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mersin University</investigator_affiliation>
      <investigator_full_name>Hilmi Bozkurt</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Bowel preparation</keyword>
    <keyword>Colonoscopy</keyword>
    <keyword>Sennoside A+B calcium</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021639
  org study id: Mersin2023
  nct id: NCT06021639
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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'.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Diagnostic
  masking: Single (Investigator)
  masking description: Randomization will be planned 1 to 1 according to the order of application. Randomization will be planned by the endoscopy nurse in the endoscopy unit and will not be known to the endoscopist who will perform the procedure.
  measure: Cleaning during colonoscopy
  time frame: During the colonoscopy procedure
  description: 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
  arm group label: Low fiber diet group
  arm group type: Experimental
  description: 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 group label: Clear diet group
  arm group type: No Intervention
  description: 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.
  intervention type: Dietary Supplement
  intervention name: The last 24 hours will consume low fiber food.
  description: 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.
  arm group label: Low fiber diet group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hilmi Bozkurt
  role: Principal Investigator
  affiliation: Mersin University
  last name: Hilmi Bozkurt
  phone: +90 324 361 00 01
  email: hilmibozkurt@mersin.edu.tr
  facility: 
  contact: 
  country: Turkey
  citation: 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.
  PMID: 23039803
  citation: 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.
  PMID: 31258137
  citation: Labianca R, Merelli B. Screening and diagnosis for colorectal cancer: present and future. Tumori. 2010 Nov-Dec;96(6):889-901.
  PMID: 21388049
  citation: 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.
  PMID: 9199899
  citation: 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.
  PMID: 23335011
  citation: Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.
  PMID: 22104756
  responsible party type: Principal Investigator
  investigator affiliation: Mersin University
  investigator full name: Hilmi Bozkurt
  investigator title: Associate Professor