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Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
midline incision or off-midline incision
Sponsored by
Hiroki Yamaue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Tumor size is less than 5cm
  • No history of laparotomy
  • No bowel obstruction by tumor

Exclusion Criteria:

  • Patients who can't respond to medical question
  • Patients who receive steroids or insulin therapy
  • Uncontrolled DM
  • Severe respiratory failure(HOT)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Midline incision

    off-midline incision

    Arm Description

    The extraction-site incision in laparoscopic colectomy is middline

    The extraction-site incision in laparoscopic colectomy is off-middline

    Outcomes

    Primary Outcome Measures

    cosmetic effect
    Scar assessment score on the patient and observer scar assessment scale(POSAS)

    Secondary Outcome Measures

    Quality of life
    Questionnaire on the SF-36 v2 acute

    Full Information

    First Posted
    September 24, 2014
    Last Updated
    September 26, 2014
    Sponsor
    Hiroki Yamaue
    Collaborators
    Katsunari Takifuji
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02253303
    Brief Title
    Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
    Official Title
    Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hiroki Yamaue
    Collaborators
    Katsunari Takifuji

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Midline incision
    Arm Type
    Experimental
    Arm Description
    The extraction-site incision in laparoscopic colectomy is middline
    Arm Title
    off-midline incision
    Arm Type
    Active Comparator
    Arm Description
    The extraction-site incision in laparoscopic colectomy is off-middline
    Intervention Type
    Other
    Intervention Name(s)
    midline incision or off-midline incision
    Intervention Description
    Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
    Primary Outcome Measure Information:
    Title
    cosmetic effect
    Description
    Scar assessment score on the patient and observer scar assessment scale(POSAS)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Quality of life
    Description
    Questionnaire on the SF-36 v2 acute
    Time Frame
    7 days, 14 days and 30 days
    Other Pre-specified Outcome Measures:
    Title
    Incisional hernia
    Description
    Numbers of participants with incisional hernia
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Tumor size is less than 5cm No history of laparotomy No bowel obstruction by tumor Exclusion Criteria: Patients who can't respond to medical question Patients who receive steroids or insulin therapy Uncontrolled DM Severe respiratory failure(HOT)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katsunari Takifuji
    Phone
    073-447-2300
    Ext
    5112
    Email
    takifuji@wakayama-med.ac.jp
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tsukasa Hotta
    Phone
    073-447-2300
    Ext
    5112
    Email
    hotta@wakayama-med.ac.jp
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    HIroki Yamaue, Chief prof.
    Organizational Affiliation
    Second Department of Surgery, Wakayama Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23375702
    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.
    Results Reference
    background
    PubMed Identifier
    18347858
    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.
    Results Reference
    background
    PubMed Identifier
    22580878
    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.
    Results Reference
    background

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    Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-

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