<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/NCT01675739</url>
  </required_header>
  <id_info>
    <org_study_id>SMS-CFS</org_study_id>
    <nct_id>NCT01675739</nct_id>
  </id_info>
  <brief_title>Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy</brief_title>
  <official_title>Effectiveness of Fixed Preparation-to-Colonoscopy Interval Using Short Message Service (SMS) for Afternoon Colonoscopy: a Randomized Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of SMS (short message service of&#xD;
      mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bowel preparation quality for colonoscopy is influenced by several factors and&#xD;
      preparation-to-colonoscopy (PC) interval is one of the important factors. The bowel&#xD;
      preparation with split-dose PEG (polyethylene glycol) is an obviously uncomfortable process,&#xD;
      it is usually difficult to ingest PEG in time. Therefore, the investigators conducted a&#xD;
      prospective randomized control study to evaluate the effectiveness of fixed PC interval for&#xD;
      satisfactory bowel preparation in the afternoon colonoscopy using mobile phone short message&#xD;
      service (SMS), which reported that it could increase patient's compliance in other practical&#xD;
      era&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Ottawa bowel preparation scale</measure>
    <time_frame>at the end of time of the colonoscopic examination (about 30 minutes-1hour)</time_frame>
    <description>This scale assesses cleanliness and fluid volume respectively and presents the total score as sum of these two values. Cleanliness was assessed for the right colon (cecum, ascending colon), midcolon (transverse, descending colon), and the rectosigmoid colon; each colon section was individually rated from 0 to 4 (0 = no liquid, 1 = minimal liquid, no suction required, 2 = suction required to see mucosa, 3 = wash and suction required, 4 = solid stool, not washable). Fluid quantity was rated from 0 to 2 for the entire colon (0 = minimal, 1 = moderate, 2 = large). The Ottawa Scale scores range from 0 (perfect) to 14 (solid stool in each colon segment and large amount of fluid).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Effectiveness of SMS to Fix PC Interval</condition>
  <arm_group>
    <arm_group_label>No-SMS group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy without SMS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled short message service(SMS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short message service of mobile phone (SMS)</intervention_name>
    <description>In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy.</description>
    <arm_group_label>SMS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>polyethylene glycol (PEG)</intervention_name>
    <description>No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy.&#xD;
SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS</description>
    <arm_group_label>No-SMS group</arm_group_label>
    <arm_group_label>SMS group</arm_group_label>
    <other_name>Colyte</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 and 80 years who were scheduled for afternoon colonoscopy (screening or&#xD;
             surveillance)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unavailable mobile phone nor SMS&#xD;
&#xD;
          -  age younger than 18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  history of large-bowel resection&#xD;
&#xD;
          -  renal failure (serum creatinine ≥ 3.0 mg/dL [normal 0.8-1.4])&#xD;
&#xD;
          -  drug addiction or major psychiatric illness&#xD;
&#xD;
          -  allergy to PEG&#xD;
&#xD;
          -  refusal to participate in the study.&#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>Tae Oh Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine</name>
      <address>
        <city>Busan</city>
        <zip>612-030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Jongha Park</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>bowel preparation</keyword>
  <keyword>short message service</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01675739
org study id: SMS-CFS
nct id: NCT01675739
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effectiveness of SMS (short message service of
      mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.
Bowel preparation quality for colonoscopy is influenced by several factors and
      preparation-to-colonoscopy (PC) interval is one of the important factors. The bowel
      preparation with split-dose PEG (polyethylene glycol) is an obviously uncomfortable process,
      it is usually difficult to ingest PEG in time. Therefore, the investigators conducted a
      prospective randomized control study to evaluate the effectiveness of fixed PC interval for
      satisfactory bowel preparation in the afternoon colonoscopy using mobile phone short message
      service (SMS), which reported that it could increase patient's compliance in other practical
      era
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: the Ottawa bowel preparation scale
time frame: at the end of time of the colonoscopic examination (about 30 minutes-1hour)
description: This scale assesses cleanliness and fluid volume respectively and presents the total score as sum of these two values. Cleanliness was assessed for the right colon (cecum, ascending colon), midcolon (transverse, descending colon), and the rectosigmoid colon; each colon section was individually rated from 0 to 4 (0 = no liquid, 1 = minimal liquid, no suction required, 2 = suction required to see mucosa, 3 = wash and suction required, 4 = solid stool, not washable). Fluid quantity was rated from 0 to 2 for the entire colon (0 = minimal, 1 = moderate, 2 = large). The Ottawa Scale scores range from 0 (perfect) to 14 (solid stool in each colon segment and large amount of fluid).
arm group label: No-SMS group
arm group type: Active Comparator
description: In No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy without SMS.
arm group label: SMS group
arm group type: Experimental
description: Patients in SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled short message service(SMS)
intervention type: Behavioral
intervention name: Short message service of mobile phone (SMS)
description: In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy.
arm group label: SMS group
intervention type: Drug
intervention name: polyethylene glycol (PEG)
description: No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy.
SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS
arm group label: No-SMS group
arm group label: SMS group
other name: Colyte
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tae Oh Kim
role: Principal Investigator
affiliation: Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Jongha Park
investigator title: Assistant professor