<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/NCT04400669</url>
  </required_header>
  <id_info>
    <org_study_id>MBP</org_study_id>
    <nct_id>NCT04400669</nct_id>
  </id_info>
  <brief_title>The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions</brief_title>
  <official_title>The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Pressure of Pneumoperitoneum and Trendelenburg Inclination Angle During the Surgery: A Novel Perspective for Patient Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ondokuz Mayıs University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This RCT aims to investigate the real surgical effects of MBP prior to the gynecological&#xD;
      laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest&#xD;
      Trendelenburg inclination angle, the ease of the surgical view and the preferences of the&#xD;
      patients with objective measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive&#xD;
      gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and&#xD;
      visualization of the surgical field, and also to reduce faecal contamination in the setting&#xD;
      of bowel injury and/or resection.&#xD;
&#xD;
      The studies investigating the effect of MBP on MIGP are limited and most of existing data are&#xD;
      extrapolated from the reports of colorectal and urological surgery studies.&#xD;
&#xD;
      Besides, evaluation of the surgical workspace visualization and intraoperative bowel handling&#xD;
      are far from being objective since they were mostly measured by a 4/5/10-point Likert scales&#xD;
      or rated verbally on scales of excellent to poor by the operating surgeons.&#xD;
&#xD;
      In contrary, it is planned to use objective visualize index, and objective surgical&#xD;
      conditions to measure whether MBP has any effect or not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">November 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 5, 2021</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Surgeons and the assessor will be blind. The nurse working in the gynecology setting perform the intervention to the previously randomized patients. Patient will be told for not to reveal the intervention that she undergoes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The surgical visibility of abdomen</measure>
    <time_frame>After the introduce of first left lateral port</time_frame>
    <description>A scale title as &quot;Objective Visual Indexing (OVI)&quot; will be used for assessing the visibility of the Douglas pouch and adnexa. The assessment of the visibility of Douglas pouch and adnexa will be performed under standard pneumoperitoneum pressure (12mmHg) and Trendelenburg inclincation angle (30). After the first Inspection, scale of VI scoring will be calculated by adding up the points obtained from optical inspection. Higher scores mean better visuality of the surgical field.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).</measure>
    <time_frame>In the initial phase of the surgery</time_frame>
    <description>The PP will be increased to 15 mmHg while keeping the TIA same, at 30o. The surgeon will displace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel was displaced out of the pelvis, the PP will be stepwise decreased by 1 mmHg during 1 min intervals to the lowest pressure where the bowel is to descend towards the pelvis over the pelvic brim and/or where the surgical workspace is not adequate to proceed safely with the planned operation. This value will be recorded as the lowest PP adequate to proceed safely with the planned surgery at standard TIA (30 degree).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.</measure>
    <time_frame>In the initial phase of the surgery</time_frame>
    <description>The PP obtained in outcome 2 will be readjusted to the standard 12 mmHg keeping the TIA same, at 300. Then, the surgeon will replace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel is displaced out of the pelvis, the TIA will be gradually decreased by 1o with 15 seconds intervals to the degree where the bowel is to descend towards the pelvis over the pelvic brim. This value will be recorded as the lowest TIA adequate to proceed safely with the planned surgery at standard PP (12 mmHg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preoperative patient symptomatology</measure>
    <time_frame>Right before the surgery</time_frame>
    <description>Patients will be interviewed in the preoperative holding area or in the patient's room about the acceptability of the intervention (MBP / diet) and adverse pre-operative events, including: nausea, insomnia, headache, thirst, weakness, tiredness, discomfort, abdominal cramps, sleep disturbances. These symptoms will be scored with using a 10-cm &quot;Visual Analog Score&quot; (VAS). Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>at 24th hours</time_frame>
    <description>The intensity of the postoperative pain was measured by an independent investigator at 24th hours with a 10-cm Visual Analog Score (VAS). Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>At 1st week and 6th week postoperatively or whenever it occurred.</time_frame>
    <description>Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Patient Preference</condition>
  <condition>Patient Safety</condition>
  <arm_group>
    <arm_group_label>Mechanical Bowel Preparation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have only clear liquids after a normal breakfast and lunch on the day before surgery and subsequently fasten for 7-9 hours prior to surgery. Patients will ingest first dose of 45 ml oral sodium phosphate (NaP) enema (BT ORAL SOLUSYON 45 ML®, Yenisehir Lab. Tic. San. Ltd. Sti, Turkey) at 4 p.m. and a second dose at 8 p.m. in the evening before the scheduled surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low fibre diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be given detailed instructions about the pre-operative diet (total daily Fibre intake inferior to 10 g) to be used for 3 days prior to surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MBP plus low fibre diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive both mechanical bowel preparation and 3-days low fibre diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control subjects will receive no instructions about the pre-operative diet (free diet).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mechanical Bowel Preparation</intervention_name>
    <description>oral sodium phosphate (NaP) enema</description>
    <arm_group_label>Mechanical Bowel Preparation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low fibre diet</intervention_name>
    <description>3 days</description>
    <arm_group_label>Low fibre diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MBP plus low-fibre diet</intervention_name>
    <description>3 days low fibre diet preoperative mechanical bowel preparation</description>
    <arm_group_label>MBP plus low fibre diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years and older&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Undergo laparoscopic gynecological surgery for a benign condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous abdominal surgery&#xD;
&#xD;
          -  Clinically significant present or past systemic diseases&#xD;
&#xD;
          -  Inability to perform mechanical bowel preparation&#xD;
&#xD;
          -  Suspicion of malignancy&#xD;
&#xD;
          -  Association with non-gynaecological surgical pathologies&#xD;
&#xD;
          -  Severe endometriosis (stage ≥ III according to the classification of the American&#xD;
             Society for Reproductive Medicine)&#xD;
&#xD;
          -  Psychiatric disorders precluding consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kadir Bakay, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ondokuz Mayis Universitesi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uzeyir Kalkan, M.D.</last_name>
    <phone>+905428102539</phone>
    <email>uzekal@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Egemed Hospital</name>
      <address>
        <city>Aydin</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Uzeyir Kalkan, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Uzeyir Kalkan, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Samsun Medical Faculty</name>
      <address>
        <city>Samsun</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kadir Bakay, Assoc.Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Kadir Bakay, Assoc.Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Bakay K, Aytekin F. Mechanical bowel preparation for laparoscopic hysterectomy, is it really necessary? J Obstet Gynaecol. 2017 Nov;37(8):1032-1035. doi: 10.1080/01443615.2017.1318268. Epub 2017 Jun 26.</citation>
    <PMID>28650683</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
    <investigator_full_name>Kadir Bakay</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>mechanical bowel preparation</keyword>
  <keyword>gynecological surgery</keyword>
  <keyword>Minimally invasive gynecological procedures</keyword>
  <keyword>Enema</keyword>
  <keyword>Trendelenburg angle</keyword>
  <keyword>Pneumoperitoneum pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumoperitoneum</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Raw data (for meta-analysis), statistical analyses and study protocol can be shared upon request. Processed data can be shared after completion of the study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After the completion of the study, for 10 years.</ipd_time_frame>
    <ipd_access_criteria>Access will be granted right after establishing a contact.</ipd_access_criteria>
    <ipd_url>https://drive.google.com/file/d/1E5qV7Ff_ltsXFYc0m4MgO2a4N-BmVRSQ/view?usp=sharing</ipd_url>
  </patient_data>
  <!-- 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/NCT04400669
org study id: MBP
nct id: NCT04400669
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This RCT aims to investigate the real surgical effects of MBP prior to the gynecological
      laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest
      Trendelenburg inclination angle, the ease of the surgical view and the preferences of the
      patients with objective measures.
Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive
      gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and
      visualization of the surgical field, and also to reduce faecal contamination in the setting
      of bowel injury and/or resection.

      The studies investigating the effect of MBP on MIGP are limited and most of existing data are
      extrapolated from the reports of colorectal and urological surgery studies.

      Besides, evaluation of the surgical workspace visualization and intraoperative bowel handling
      are far from being objective since they were mostly measured by a 4/5/10-point Likert scales
      or rated verbally on scales of excellent to poor by the operating surgeons.

      In contrary, it is planned to use objective visualize index, and objective surgical
      conditions to measure whether MBP has any effect or not.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: Surgeons and the assessor will be blind. The nurse working in the gynecology setting perform the intervention to the previously randomized patients. Patient will be told for not to reveal the intervention that she undergoes.
measure: The surgical visibility of abdomen
time frame: After the introduce of first left lateral port
description: A scale title as "Objective Visual Indexing (OVI)" will be used for assessing the visibility of the Douglas pouch and adnexa. The assessment of the visibility of Douglas pouch and adnexa will be performed under standard pneumoperitoneum pressure (12mmHg) and Trendelenburg inclincation angle (30). After the first Inspection, scale of VI scoring will be calculated by adding up the points obtained from optical inspection. Higher scores mean better visuality of the surgical field.
measure: The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).
time frame: In the initial phase of the surgery
description: The PP will be increased to 15 mmHg while keeping the TIA same, at 30o. The surgeon will displace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel was displaced out of the pelvis, the PP will be stepwise decreased by 1 mmHg during 1 min intervals to the lowest pressure where the bowel is to descend towards the pelvis over the pelvic brim and/or where the surgical workspace is not adequate to proceed safely with the planned operation. This value will be recorded as the lowest PP adequate to proceed safely with the planned surgery at standard TIA (30 degree).
measure: The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.
time frame: In the initial phase of the surgery
description: The PP obtained in outcome 2 will be readjusted to the standard 12 mmHg keeping the TIA same, at 300. Then, the surgeon will replace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel is displaced out of the pelvis, the TIA will be gradually decreased by 1o with 15 seconds intervals to the degree where the bowel is to descend towards the pelvis over the pelvic brim. This value will be recorded as the lowest TIA adequate to proceed safely with the planned surgery at standard PP (12 mmHg).
measure: Preoperative patient symptomatology
time frame: Right before the surgery
description: Patients will be interviewed in the preoperative holding area or in the patient's room about the acceptability of the intervention (MBP / diet) and adverse pre-operative events, including: nausea, insomnia, headache, thirst, weakness, tiredness, discomfort, abdominal cramps, sleep disturbances. These symptoms will be scored with using a 10-cm "Visual Analog Score" (VAS). Higher scores mean worse outcome.
measure: Postoperative pain
time frame: at 24th hours
description: The intensity of the postoperative pain was measured by an independent investigator at 24th hours with a 10-cm Visual Analog Score (VAS). Higher scores mean worse outcome.
measure: Complications
time frame: At 1st week and 6th week postoperatively or whenever it occurred.
description: Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.
arm group label: Mechanical Bowel Preparation
arm group type: Experimental
description: Patients will have only clear liquids after a normal breakfast and lunch on the day before surgery and subsequently fasten for 7-9 hours prior to surgery. Patients will ingest first dose of 45 ml oral sodium phosphate (NaP) enema (BT ORAL SOLUSYON 45 ML®, Yenisehir Lab. Tic. San. Ltd. Sti, Turkey) at 4 p.m. and a second dose at 8 p.m. in the evening before the scheduled surgery.
arm group label: Low fibre diet
arm group type: Active Comparator
description: Patients will be given detailed instructions about the pre-operative diet (total daily Fibre intake inferior to 10 g) to be used for 3 days prior to surgery.
arm group label: MBP plus low fibre diet
arm group type: Active Comparator
description: This group will receive both mechanical bowel preparation and 3-days low fibre diet.
arm group label: Control
arm group type: No Intervention
description: Control subjects will receive no instructions about the pre-operative diet (free diet).
intervention type: Other
intervention name: Mechanical Bowel Preparation
description: oral sodium phosphate (NaP) enema
arm group label: Mechanical Bowel Preparation
intervention type: Dietary Supplement
intervention name: Low fibre diet
description: 3 days
arm group label: Low fibre diet
intervention type: Other
intervention name: MBP plus low-fibre diet
description: 3 days low fibre diet preoperative mechanical bowel preparation
arm group label: MBP plus low fibre diet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kadir Bakay, Assoc Prof
role: Principal Investigator
affiliation: Ondokuz Mayis Universitesi
last name: Uzeyir Kalkan, M.D.
phone: +905428102539
email: uzekal@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
citation: Bakay K, Aytekin F. Mechanical bowel preparation for laparoscopic hysterectomy, is it really necessary? J Obstet Gynaecol. 2017 Nov;37(8):1032-1035. doi: 10.1080/01443615.2017.1318268. Epub 2017 Jun 26.
PMID: 28650683
responsible party type: Principal Investigator
investigator affiliation: Ondokuz Mayıs University
investigator full name: Kadir Bakay
investigator title: Associate Professor
mesh term: Pneumoperitoneum
sharing ipd: Yes
ipd description: Raw data (for meta-analysis), statistical analyses and study protocol can be shared upon request. Processed data can be shared after completion of the study.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: After the completion of the study, for 10 years.
ipd access criteria: Access will be granted right after establishing a contact.
ipd url: https://drive.google.com/file/d/1E5qV7Ff_ltsXFYc0m4MgO2a4N-BmVRSQ/view?usp=sharing