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Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

Primary Purpose

Colorectal Obstruction, Left Colonic Adenocarcinoma

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stent
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Obstruction focused on measuring colorectal stents, colonic obstruction, colonic adenocarcinoma, colorectal surgery

Eligibility Criteria

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

Inclusion Criteria:

  • obstructive stenosis due to left colorectal cancer

Exclusion Criteria:

  • previous colorectal cancer
  • other colorectal location

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    primary surgery group

    Outcomes

    Primary Outcome Measures

    number of stoma in each group

    Secondary Outcome Measures

    mortality in each group
    complications
    number of procedures
    length of stay

    Full Information

    First Posted
    August 8, 2007
    Last Updated
    August 8, 2007
    Sponsor
    University Hospital, Montpellier
    Collaborators
    University Hospital, Rouen, University Hospital, Toulouse, University Hospital, Grenoble, Rennes University Hospital, University Hospital, Lille, University Hospital, Angers, University Hospital, Bordeaux
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00514332
    Brief Title
    Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study
    Official Title
    Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    enrolling participants stopped
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Montpellier
    Collaborators
    University Hospital, Rouen, University Hospital, Toulouse, University Hospital, Grenoble, Rennes University Hospital, University Hospital, Lille, University Hospital, Angers, University Hospital, Bordeaux

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate wether colorectal stenting carry a significant clinical advantage
    Detailed Description
    Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Obstruction, Left Colonic Adenocarcinoma
    Keywords
    colorectal stents, colonic obstruction, colonic adenocarcinoma, colorectal surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    primary surgery group
    Intervention Type
    Procedure
    Intervention Name(s)
    stent
    Other Intervention Name(s)
    self-expending metallic stents
    Intervention Description
    stent placement for colorectal cancer obstruction
    Primary Outcome Measure Information:
    Title
    number of stoma in each group
    Time Frame
    within the first 6 month(plus or minus 1 month) after surgery
    Secondary Outcome Measure Information:
    Title
    mortality in each group
    Time Frame
    within the first 6 month (plus or minus 1 month) after surgery
    Title
    complications
    Time Frame
    within the first 6 month (plus or minus 1 month) after surgery
    Title
    number of procedures
    Time Frame
    within the first 6 month (plus or minus 1 month) after surgery
    Title
    length of stay
    Time Frame
    within the first 6 month (plus or minus 1 month) after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: obstructive stenosis due to left colorectal cancer Exclusion Criteria: previous colorectal cancer other colorectal location
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bertrand L MILLAT, MD-PhD
    Organizational Affiliation
    University Hospital, Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21170659
    Citation
    Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
    Results Reference
    derived

    Learn more about this trial

    Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

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