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Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer. (ISR-TME)

Primary Purpose

Low Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
laparoscopic intersphincteric resection
open intersphincteric resection
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Rectal Cancer focused on measuring Intersphincteric resection, laparoscopic rectal rescetion, total mesorectal excsison

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low rectal cancer below 5 cm from the anal verge
  • Fit for laparoscopic total mesorectal excsion
  • T2, T3 rectal cancer
  • No distant metstasis

Exclusion Criteria:

  • T1, AND T4
  • Distant metastasis
  • Tumor infiltrating the dentate line
  • unwilling to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Laparoscopic group

    Open group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Disease Free survival

    Secondary Outcome Measures

    Local recurrence
    Distant metstasis
    5 year survival

    Full Information

    First Posted
    June 7, 2015
    Last Updated
    June 9, 2015
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02468362
    Brief Title
    Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.
    Acronym
    ISR-TME
    Official Title
    Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    5. Study Description

    Brief Summary
    Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Rectal Cancer
    Keywords
    Intersphincteric resection, laparoscopic rectal rescetion, total mesorectal excsison

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic group
    Arm Type
    Active Comparator
    Arm Title
    Open group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic intersphincteric resection
    Intervention Description
    laparoscopic intersphincteric resection for low rectal cancer
    Intervention Type
    Procedure
    Intervention Name(s)
    open intersphincteric resection
    Primary Outcome Measure Information:
    Title
    Disease Free survival
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Local recurrence
    Time Frame
    5 years
    Title
    Distant metstasis
    Time Frame
    5 years
    Title
    5 year survival
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Low rectal cancer below 5 cm from the anal verge Fit for laparoscopic total mesorectal excsion T2, T3 rectal cancer No distant metstasis Exclusion Criteria: T1, AND T4 Distant metastasis Tumor infiltrating the dentate line unwilling to participate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Osama Eldamshety, PhD, MD
    Organizational Affiliation
    Oncology centre of mansoura university
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sherif Kotb, PhD, MD
    Organizational Affiliation
    Oncology centre of mansoura university
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nazem Shams, PhD, MD
    Organizational Affiliation
    Oncology centre of mansoura university
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ashraf Khater, Phd, MD
    Organizational Affiliation
    Oncology centre of mansoura university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.

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