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

NCT ID: NCT02318615

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Lymphedema Breast Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Immediate Axillary Plasty

Intervention Type PROCEDURE

Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immediate Axillary Plasty

Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Houpu Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

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Houpu Yang, MD

Role: CONTACT

[email protected]
86-10-88324010

Other Identifiers

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PKUPHBR001

Identifier Type: OTHER

Identifier Source: secondary_id

AxLD

Identifier Type: -

Identifier Source: org_study_id