Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention
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|ClinicalTrials.gov Identifier: NCT02318615|
Recruitment Status : Not yet recruiting
First Posted : December 17, 2014
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema Breast Neoplasm||Procedure: Immediate Axillary Plasty||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||December 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2020|
Experimental: Immediate Axillary Plasty
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.
Procedure: Immediate Axillary Plasty
Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.
No Intervention: Education
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.
- Incidence of lymphedema and/or severity of lymphedema [ Time Frame: Up to 3 years ]
- Shoulder Mobility [ Time Frame: up to 3 years ]Shoulder Mobility： the difference between baseline and postoperation，including flexion extension rotation abduction and adduction.
- Postoperation seroma [ Time Frame: up to one month ]The incidence of axilla and donor site
- Acute Upper limb thrombosis [ Time Frame: Up to one month ]The incidence of thrombosis linked to postoperation immobility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318615
|Contact: Houpu Yang, MDfirstname.lastname@example.org|
|Principal Investigator:||Houpu Yang, MD||Peking University People's Hospital|