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Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer (TAMIS)

Primary Purpose

Low Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transanal minimally invasive total mesorectal excision
transanal minimally invasive locoregional resection
Sponsored by
Osama Mohammad Ali ElDamshety
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Rectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • T2 N0 low rectal cancer

Exclusion Criteria:

  • patients unfit for laparoscopic resection
  • Unwilling to share in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TAMIS TME

    TAMIS-Local

    Arm Description

    T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.

    T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.

    Outcomes

    Primary Outcome Measures

    Overall percent of postoperative complications.
    the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.

    Secondary Outcome Measures

    Hospital stay
    Number of Days starting from the admission till discharge
    Recurrence.
    number of local and distant recurrence

    Full Information

    First Posted
    June 30, 2015
    Last Updated
    September 10, 2018
    Sponsor
    Osama Mohammad Ali ElDamshety
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02488577
    Brief Title
    Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer
    Acronym
    TAMIS
    Official Title
    Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Osama Mohammad Ali ElDamshety

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TAMIS TME
    Arm Type
    Active Comparator
    Arm Description
    T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.
    Arm Title
    TAMIS-Local
    Arm Type
    Active Comparator
    Arm Description
    T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.
    Intervention Type
    Procedure
    Intervention Name(s)
    Transanal minimally invasive total mesorectal excision
    Intervention Type
    Procedure
    Intervention Name(s)
    transanal minimally invasive locoregional resection
    Primary Outcome Measure Information:
    Title
    Overall percent of postoperative complications.
    Description
    the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Hospital stay
    Description
    Number of Days starting from the admission till discharge
    Time Frame
    30 days
    Title
    Recurrence.
    Description
    number of local and distant recurrence
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: T2 N0 low rectal cancer Exclusion Criteria: patients unfit for laparoscopic resection Unwilling to share in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherif Kotb, M.D., PhD.
    Organizational Affiliation
    Professor of surgical oncology Mansoura university
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Osama Eldamshety, PhD
    Organizational Affiliation
    surgical oncology Mansoura university
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Adel Fathi, M.D.
    Organizational Affiliation
    surgical oncology Mansoura university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer

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