<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/NCT02263443</url>
  </required_header>
  <id_info>
    <org_study_id>OBG-2557-02203</org_study_id>
    <nct_id>NCT02263443</nct_id>
  </id_info>
  <brief_title>Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery</brief_title>
  <official_title>Appropriated Bowel Preparation Before Exploratory Laparotomy in Gynecologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiang Mai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prapaporn Suprasert</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chiang Mai University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our study perform In Department of Gynecology, Faculty of Medicine, Chiang Mai University. In&#xD;
      our study we divide patients into 3 groups ,First group patients doing Soap suds enema&#xD;
      (S.S.E.), second group patients doing sodium chloride enema and the last group patient Non&#xD;
      per os (NPO) before surgery. Our hypothesis is no different about surgical view in 3 groups&#xD;
      and lower side effects in patients in no bowel preparation group.&#xD;
&#xD;
      Research objectives&#xD;
&#xD;
        1. Comparing the surgeon satisfaction ,surgical view and bowel handling in operation of&#xD;
           soap suds enema group, sodium chloride enema group and the NPO group in patients under&#xD;
           going exploratory laparotomy in gynecologic surgery.&#xD;
&#xD;
        2. Comparing the side effects of soap suds enema group, sodium chloride enema group and the&#xD;
           NPO group.&#xD;
&#xD;
      Inclusion Criteria&#xD;
&#xD;
      1. Women under going laparotomy in gynecologic surgery 2. Surgeon consider not too difficult&#xD;
      surgery. 3. Can understanding Thai language. 4. Can communicate with researcher. 5.&#xD;
      Consenting participants. Exclusion Criteria&#xD;
&#xD;
        1. Pregnancy or suspected pregnancy.&#xD;
&#xD;
        2. Laparoscopic surgery&#xD;
&#xD;
        3. Do not consent to participate in research&#xD;
&#xD;
        4. Gastrointestinal infection&#xD;
&#xD;
        5. Underlying disease such as Intestinal disease, patient who cannot under going bowel&#xD;
           preparation ,heart disease ,seizure.&#xD;
&#xD;
        6. Surgeon consider difficult surgery such as fixed mass or uterus with others organs from&#xD;
           per vaginal examination or very huge mass or history of difficult surgery or history of&#xD;
           severe adhesion in abdominal cavity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods&#xD;
&#xD;
        1. Divide patients into 3 groups ,First group patients doing Soap suds enema (S.S.E.),&#xD;
           second group patients doing sodium chloride enema and the last group patient Non per os&#xD;
           (NPO) before surgery&#xD;
&#xD;
        2. Patients information such as age, height, weight, smoking, history of surgery, number of&#xD;
           surgeries, diagnosis that required surgery. The complete blood count and the laboratory&#xD;
           prior to surgery record by the research team.&#xD;
&#xD;
        3. Patients do self questionnaire about symptoms such as abdominal pain or discomfort ,&#xD;
           anxiety ,nausea and vomiting etc. these are for understanding symptoms of patients&#xD;
           before bowel preparation perform.&#xD;
&#xD;
        4. Computer-generated sequence into block for 30 person&#xD;
&#xD;
        5. Random into 3 groups by nurses .in opaque envelopes with number infront of to identify&#xD;
           patients. Surgeon must not know what group of these patients get in.&#xD;
&#xD;
        6. Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night&#xD;
           before surgery.&#xD;
&#xD;
        7. Patients in unison enema group will Unison enema 100 ml per rectal at night before&#xD;
           surgery&#xD;
&#xD;
        8. Patients NPO groups will NPO and no bowel preparation.&#xD;
&#xD;
        9. Patients in all group are doing operative preparation such as NPO after midnight,&#xD;
           retained foley catheter and clean abdomen and perineum before surgery. Closs matching&#xD;
           blood.&#xD;
&#xD;
       10. In the morning before surgery , patients do self questionnaire about symptoms score such&#xD;
           as abdominal pain or discomfort , anxiety ,nausea and vomiting etc. for symptoms of&#xD;
           patients after bowel preparation perform last night.&#xD;
&#xD;
       11. In operation room , surgeon evaluate surgical view, bowel handling after use swabs for&#xD;
           bowel packing and record by nurse and after operation finish surgeon evaluate&#xD;
           satisfaction of operation.&#xD;
&#xD;
       12. One day after surgery and before discharge from hospital patients do self questionnaire&#xD;
           about symptoms score such as abdominal pain or discomfort , anxiety ,nausea and vomiting&#xD;
           etc&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>surgical view and bowel handling in operation</measure>
    <time_frame>1 day after bowel preparation</time_frame>
    <description>surgeon evaluate surgical view, bowel handling after use swabs for bowel packing and record by nurse and after operation finish surgeon evaluate satisfaction of operation.&#xD;
Evaluation in operation&#xD;
In operation room , surgeon evaluate surgical view, bowel handling after use swabs for bowel packing and record by nurse using visual analog scale score 0 to 10 that depend on surgical view and bowel handling, 0 is the worst surgical view and hardest bowel handling and 10 for extremely good surgical view and easiest bowel handling.&#xD;
When the operation finished surgeon evaluate satisfaction of operation .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparing the side effects of soap suds enema group, sodium chloride enema group and the NPO group.</measure>
    <time_frame>1 day before surgery and 3 day after surgery</time_frame>
    <description>Patients self answers Questionnaire about symptoms by visual analog scale score 0 to 10 that depend on severity of symptoms 0 is no symptoms and 10 most severe symptoms.&#xD;
Symptoms including headache, nausea, vomiting, thirsty, fatique, anxious, discomfort, abdominal pain , bloating, insomnia, ashamed, fecal incontinence.&#xD;
Additional questions in morning before surgery are Do you feelng discomfort from these bowel preparation?, do you want to do the same bowel preparation method if you have to do next operation? and do you want to change to other methods?,</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Cathartic Colon</condition>
  <condition>Other Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Soap sus enema (S.S.E.)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in S.S.E. group will receive bowel preparation by soap suds enema until clear at night before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sodium chloride enema</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in unison enema group will receive Unison enema 100 ml per rectal at night before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no enema</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive none of bowel preparation. NPO after midnight</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Soap suds enema (S.S.E.)</intervention_name>
    <description>Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.</description>
    <arm_group_label>Soap sus enema (S.S.E.)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sodium chloride enema</intervention_name>
    <description>Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery</description>
    <arm_group_label>sodium chloride enema</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No enema</intervention_name>
    <description>Patients NPO groups will NPO and no bowel preparation.</description>
    <arm_group_label>no enema</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women under going laparotomy in gynecologic surgery&#xD;
&#xD;
          2. Surgeon consider not too difficult surgery.&#xD;
&#xD;
          3. Can understanding Thai language.&#xD;
&#xD;
          4. Can communicate with researcher.&#xD;
&#xD;
          5. Consenting participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or suspected pregnancy.&#xD;
&#xD;
          2. Laparoscopic surgery&#xD;
&#xD;
          3. Do not consent to participate in research&#xD;
&#xD;
          4. Gastrointestinal infection&#xD;
&#xD;
          5. Underlying disease such as Intestinal disease, patient who cannot under going bowel&#xD;
             preparation ,heart disease ,seizure.&#xD;
&#xD;
          6. Surgeon consider difficult surgery such as fixed mass or uterus with others organs&#xD;
             from per vaginal examination or very huge mass or history of difficult surgery or&#xD;
             history of severe adhesion in abdominal cavity.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prapaporn - Suprasert</last_name>
    <role>Study Director</role>
    <affiliation>Chiang Mai University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University</name>
      <address>
        <city>Amphoe Muang</city>
        <state>Chiang Mai</state>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>November 19, 2015</last_update_submitted>
  <last_update_submitted_qc>November 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiang Mai University</investigator_affiliation>
    <investigator_full_name>Wasakorn Suadee</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>bowel preparation</keyword>
  <keyword>gynecologic surgery</keyword>
  <keyword>laparotomy</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/NCT02263443
org study id: OBG-2557-02203
nct id: NCT02263443
lead sponsor: 
collaborator: 
has dmc: No
Our study perform In Department of Gynecology, Faculty of Medicine, Chiang Mai University. In
      our study we divide patients into 3 groups ,First group patients doing Soap suds enema
      (S.S.E.), second group patients doing sodium chloride enema and the last group patient Non
      per os (NPO) before surgery. Our hypothesis is no different about surgical view in 3 groups
      and lower side effects in patients in no bowel preparation group.

      Research objectives

        1. Comparing the surgeon satisfaction ,surgical view and bowel handling in operation of
           soap suds enema group, sodium chloride enema group and the NPO group in patients under
           going exploratory laparotomy in gynecologic surgery.

        2. Comparing the side effects of soap suds enema group, sodium chloride enema group and the
           NPO group.

      Inclusion Criteria

      1. Women under going laparotomy in gynecologic surgery 2. Surgeon consider not too difficult
      surgery. 3. Can understanding Thai language. 4. Can communicate with researcher. 5.
      Consenting participants. Exclusion Criteria

        1. Pregnancy or suspected pregnancy.

        2. Laparoscopic surgery

        3. Do not consent to participate in research

        4. Gastrointestinal infection

        5. Underlying disease such as Intestinal disease, patient who cannot under going bowel
           preparation ,heart disease ,seizure.

        6. Surgeon consider difficult surgery such as fixed mass or uterus with others organs from
           per vaginal examination or very huge mass or history of difficult surgery or history of
           severe adhesion in abdominal cavity.
Methods

        1. Divide patients into 3 groups ,First group patients doing Soap suds enema (S.S.E.),
           second group patients doing sodium chloride enema and the last group patient Non per os
           (NPO) before surgery

        2. Patients information such as age, height, weight, smoking, history of surgery, number of
           surgeries, diagnosis that required surgery. The complete blood count and the laboratory
           prior to surgery record by the research team.

        3. Patients do self questionnaire about symptoms such as abdominal pain or discomfort ,
           anxiety ,nausea and vomiting etc. these are for understanding symptoms of patients
           before bowel preparation perform.

        4. Computer-generated sequence into block for 30 person

        5. Random into 3 groups by nurses .in opaque envelopes with number infront of to identify
           patients. Surgeon must not know what group of these patients get in.

        6. Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night
           before surgery.

        7. Patients in unison enema group will Unison enema 100 ml per rectal at night before
           surgery

        8. Patients NPO groups will NPO and no bowel preparation.

        9. Patients in all group are doing operative preparation such as NPO after midnight,
           retained foley catheter and clean abdomen and perineum before surgery. Closs matching
           blood.

       10. In the morning before surgery , patients do self questionnaire about symptoms score such
           as abdominal pain or discomfort , anxiety ,nausea and vomiting etc. for symptoms of
           patients after bowel preparation perform last night.

       11. In operation room , surgeon evaluate surgical view, bowel handling after use swabs for
           bowel packing and record by nurse and after operation finish surgeon evaluate
           satisfaction of operation.

       12. One day after surgery and before discharge from hospital patients do self questionnaire
           about symptoms score such as abdominal pain or discomfort , anxiety ,nausea and vomiting
           etc
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
measure: surgical view and bowel handling in operation
time frame: 1 day after bowel preparation
description: surgeon evaluate surgical view, bowel handling after use swabs for bowel packing and record by nurse and after operation finish surgeon evaluate satisfaction of operation.
Evaluation in operation
In operation room , surgeon evaluate surgical view, bowel handling after use swabs for bowel packing and record by nurse using visual analog scale score 0 to 10 that depend on surgical view and bowel handling, 0 is the worst surgical view and hardest bowel handling and 10 for extremely good surgical view and easiest bowel handling.
When the operation finished surgeon evaluate satisfaction of operation .
measure: Comparing the side effects of soap suds enema group, sodium chloride enema group and the NPO group.
time frame: 1 day before surgery and 3 day after surgery
description: Patients self answers Questionnaire about symptoms by visual analog scale score 0 to 10 that depend on severity of symptoms 0 is no symptoms and 10 most severe symptoms.
Symptoms including headache, nausea, vomiting, thirsty, fatique, anxious, discomfort, abdominal pain , bloating, insomnia, ashamed, fecal incontinence.
Additional questions in morning before surgery are Do you feelng discomfort from these bowel preparation?, do you want to do the same bowel preparation method if you have to do next operation? and do you want to change to other methods?,
arm group label: Soap sus enema (S.S.E.)
arm group type: Experimental
description: Patients in S.S.E. group will receive bowel preparation by soap suds enema until clear at night before surgery.
arm group label: sodium chloride enema
arm group type: Experimental
description: Patients in unison enema group will receive Unison enema 100 ml per rectal at night before surgery.
arm group label: no enema
arm group type: Placebo Comparator
description: Patients will receive none of bowel preparation. NPO after midnight
intervention type: Procedure
intervention name: Soap suds enema (S.S.E.)
description: Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.
arm group label: Soap sus enema (S.S.E.)
intervention type: Procedure
intervention name: sodium chloride enema
description: Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
arm group label: sodium chloride enema
intervention type: Procedure
intervention name: No enema
description: Patients NPO groups will NPO and no bowel preparation.
arm group label: no enema
criteria: 
gender: Female
minimum age: N/A
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Prapaporn - Suprasert
role: Study Director
affiliation: Chiang Mai University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chiang Mai University
investigator full name: Wasakorn Suadee
investigator title: M.D.