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Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention

Primary Purpose

Lymphedema, Breast Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immediate Axillary Plasty
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphedema focused on measuring Breast Neoplasm, Lymphedema, Autologous flap, lattismus dorsi flap

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing axillary lymph node dissection

Exclusion Criteria:

  • Prior iplateral upper limb edema
  • Plan for breast or axillary reconstruction
  • The thoracodorsal vessel damage
  • Muscle flap volume too low

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Immediate Axillary Plasty

    Education

    Arm Description

    Immediate Axillary Plasty ：After axillary lymph node dissection, a pedicled flap named Partial Latissimus Dorsi Muscle Flap is filled in the cavity of axilla, and fixed around the axillary vessels.

    Education：After surgery, education on the prevention of lymphedema. In patients suffering with upper limb lymphedema during follow-up, any treatment except axillary or breast reconstruction can be used.

    Outcomes

    Primary Outcome Measures

    Incidence of lymphedema and/or severity of lymphedema

    Secondary Outcome Measures

    Shoulder Mobility
    Shoulder Mobility： the difference between baseline and postoperation，including flexion extension rotation abduction and adduction.
    Postoperation seroma
    The incidence of axilla and donor site
    Acute Upper limb thrombosis
    The incidence of thrombosis linked to postoperation immobility

    Full Information

    First Posted
    December 11, 2014
    Last Updated
    November 19, 2015
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02318615
    Brief Title
    Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention
    Official Title
    The Efficacy and Safety of Immediate Axillary Plasty With Pedicled Partial Latissimus Dorsi Muscle Flap for Lymphedema Prevention in Breast Cancer Patients Who Undergoing Axillary Dissection: a Prospective, Corhort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this comparable cohort study is to evaluate the efficacy and safety of immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema prevention in breast cancer patients who are undergoing axillary dissection.
    Detailed Description
    Upper limb lymphedema is the main complication of axillary dissection. It is estimated that as many as 50% of patients undergoing lymph node dissection go on to develop lymphedema, with significantly decreased quality of life with frequent infections, decreased range of motion, and a cosmetic deformity. The treatment of lymphedema was be frustrated by technical difficulties and gave rise to a heavy budget burden. Some retrospective studies revealed that immediate and delayed breast reconstruction with lattismus dorsi flap brought unexpected relief to the upper limb lymphedema. The current study was composed to assess whether transferring a pedicled partial latissimus dorsi muscle flap to the axilla would prevent the occurrence of post-mastectomy lymphedema. This prospectively designed cohort study have two parallel arms. Patients undergoing axillary dissection would be recruited to one of the two groups, according their own preference.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema, Breast Neoplasm
    Keywords
    Breast Neoplasm, Lymphedema, Autologous flap, lattismus dorsi flap

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate Axillary Plasty
    Arm Type
    Experimental
    Arm Description
    Immediate Axillary Plasty ：After axillary lymph node dissection, a pedicled flap named Partial Latissimus Dorsi Muscle Flap is filled in the cavity of axilla, and fixed around the axillary vessels.
    Arm Title
    Education
    Arm Type
    No Intervention
    Arm Description
    Education：After surgery, education on the prevention of lymphedema. In patients suffering with upper limb lymphedema during follow-up, any treatment except axillary or breast reconstruction can be used.
    Intervention Type
    Procedure
    Intervention Name(s)
    Immediate Axillary Plasty
    Intervention Description
    Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.
    Primary Outcome Measure Information:
    Title
    Incidence of lymphedema and/or severity of lymphedema
    Time Frame
    Up to 3 years
    Secondary Outcome Measure Information:
    Title
    Shoulder Mobility
    Description
    Shoulder Mobility： the difference between baseline and postoperation，including flexion extension rotation abduction and adduction.
    Time Frame
    up to 3 years
    Title
    Postoperation seroma
    Description
    The incidence of axilla and donor site
    Time Frame
    up to one month
    Title
    Acute Upper limb thrombosis
    Description
    The incidence of thrombosis linked to postoperation immobility
    Time Frame
    Up to one month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing axillary lymph node dissection Exclusion Criteria: Prior iplateral upper limb edema Plan for breast or axillary reconstruction The thoracodorsal vessel damage Muscle flap volume too low
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Houpu Yang, MD
    Phone
    86-10-88324010
    Email
    yanghoupu@pkuph.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Houpu Yang, MD
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention

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