<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/NCT02253303</url>
  </required_header>
  <id_info>
    <org_study_id>WMU1398</org_study_id>
    <nct_id>NCT02253303</nct_id>
  </id_info>
  <brief_title>Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-</brief_title>
  <official_title>Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hiroki Yamaue</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Katsunari Takifuji</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wakayama Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the midline extraction incision in patients with&#xD;
      colon cancer. A prospective randomized controlled trial is conducted to compare midline&#xD;
      extraction incision with off-midline extraction incision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the&#xD;
      extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in&#xD;
      laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction&#xD;
      incision in patients with colon cancer. A prospective randomized controlled trial is&#xD;
      conducted to compare midline extraction incision with off-midline extraction incision. The&#xD;
      investigators hypothesize that the use of the midline extraction incision in laparoscopic&#xD;
      colon surgery will result in more cosmetic effect and better quality of life compared to the&#xD;
      off-midline extraction incision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cosmetic effect</measure>
    <time_frame>1 year</time_frame>
    <description>Scar assessment score on the patient and observer scar assessment scale(POSAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>7 days, 14 days and 30 days</time_frame>
    <description>Questionnaire on the SF-36 v2 acute</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incisional hernia</measure>
    <time_frame>1 year</time_frame>
    <description>Numbers of participants with incisional hernia</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Midline incision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The extraction-site incision in laparoscopic colectomy is middline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>off-midline incision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The extraction-site incision in laparoscopic colectomy is off-middline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>midline incision or off-midline incision</intervention_name>
    <description>Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy</description>
    <arm_group_label>Midline incision</arm_group_label>
    <arm_group_label>off-midline incision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tumor size is less than 5cm&#xD;
&#xD;
          -  No history of laparotomy&#xD;
&#xD;
          -  No bowel obstruction by tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can't respond to medical question&#xD;
&#xD;
          -  Patients who receive steroids or insulin therapy&#xD;
&#xD;
          -  Uncontrolled DM&#xD;
&#xD;
          -  Severe respiratory failure(HOT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HIroki Yamaue, Chief prof.</last_name>
    <role>Study Director</role>
    <affiliation>Second Department of Surgery, Wakayama Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katsunari Takifuji</last_name>
    <phone>073-447-2300</phone>
    <phone_ext>5112</phone_ext>
    <email>takifuji@wakayama-med.ac.jp</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tsukasa Hotta</last_name>
    <phone>073-447-2300</phone>
    <phone_ext>5112</phone_ext>
    <email>hotta@wakayama-med.ac.jp</email>
  </overall_contact_backup>
  <reference>
    <citation>Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.</citation>
    <PMID>23375702</PMID>
  </reference>
  <reference>
    <citation>Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.</citation>
    <PMID>18347858</PMID>
  </reference>
  <reference>
    <citation>Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.</citation>
    <PMID>22580878</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 26, 2014</last_update_submitted>
  <last_update_submitted_qc>September 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wakayama Medical University</investigator_affiliation>
    <investigator_full_name>Hiroki Yamaue</investigator_full_name>
    <investigator_title>Chief and professor of second department of surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <!-- 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/NCT02253303
org study id: WMU1398
nct id: NCT02253303
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the midline extraction incision in patients with
      colon cancer. A prospective randomized controlled trial is conducted to compare midline
      extraction incision with off-midline extraction incision.
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the
      extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in
      laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction
      incision in patients with colon cancer. A prospective randomized controlled trial is
      conducted to compare midline extraction incision with off-midline extraction incision. The
      investigators hypothesize that the use of the midline extraction incision in laparoscopic
      colon surgery will result in more cosmetic effect and better quality of life compared to the
      off-midline extraction incision.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: cosmetic effect
time frame: 1 year
description: Scar assessment score on the patient and observer scar assessment scale(POSAS)
measure: Quality of life
time frame: 7 days, 14 days and 30 days
description: Questionnaire on the SF-36 v2 acute
measure: Incisional hernia
time frame: 1 year
description: Numbers of participants with incisional hernia
arm group label: Midline incision
arm group type: Experimental
description: The extraction-site incision in laparoscopic colectomy is middline
arm group label: off-midline incision
arm group type: Active Comparator
description: The extraction-site incision in laparoscopic colectomy is off-middline
intervention type: Other
intervention name: midline incision or off-midline incision
description: Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
arm group label: Midline incision
arm group label: off-midline incision
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: HIroki Yamaue, Chief prof.
role: Study Director
affiliation: Second Department of Surgery, Wakayama Medical University
last name: Katsunari Takifuji
phone: 073-447-2300
phone ext: 5112
email: takifuji@wakayama-med.ac.jp
last name: Tsukasa Hotta
phone: 073-447-2300
phone ext: 5112
email: hotta@wakayama-med.ac.jp
citation: Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.
PMID: 23375702
citation: Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.
PMID: 18347858
citation: Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.
PMID: 22580878
responsible party type: Sponsor-Investigator
investigator affiliation: Wakayama Medical University
investigator full name: Hiroki Yamaue
investigator title: Chief and professor of second department of surgery
mesh term: Surgical Wound