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Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

Primary Purpose

RECTAL CANCER

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RECTAL CANCER RESECTION
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RECTAL CANCER

Eligibility Criteria

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

Inclusion Criteria:

  • Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
  • Histology of adenocarcinoma

Exclusion Criteria:

  • Locally advanced disease (T4)
  • Emergency surgery
  • Rectal cancer over familial colic polyposis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    OPEN SURGERY

    LAPAROSCOPIC SURGERY

    Arm Description

    Outcomes

    Primary Outcome Measures

    Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2008
    Last Updated
    March 17, 2015
    Sponsor
    Hospital Universitario Virgen de la Arrixaca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00782457
    Brief Title
    Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    December 2010 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Universitario Virgen de la Arrixaca

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    RECTAL CANCER

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OPEN SURGERY
    Arm Type
    Active Comparator
    Arm Title
    LAPAROSCOPIC SURGERY
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    RECTAL CANCER RESECTION
    Primary Outcome Measure Information:
    Title
    Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin) Histology of adenocarcinoma Exclusion Criteria: Locally advanced disease (T4) Emergency surgery Rectal cancer over familial colic polyposis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19644973
    Citation
    Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.
    Results Reference
    derived

    Learn more about this trial

    Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

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