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Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

NCT ID: NCT05600153

Last Updated: 2022-10-31

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

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-12-31

Brief Summary

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The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.

Detailed Description

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Conditions

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Breast Neoplasm Female Breast Reconstruction Wound Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary breast approach

Group Type PLACEBO_COMPARATOR

implant exchange operation

Intervention Type PROCEDURE

To perform implant exchange via axillary incision.

axillary approach

Group Type EXPERIMENTAL

implant exchange operation

Intervention Type PROCEDURE

To perform implant exchange via axillary incision.

Interventions

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implant exchange operation

To perform implant exchange via axillary incision.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 + (inclusive)
* Female
* Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology
* SSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a year
* An incision on the surface of the breast is used to place an expander in the first-stage surgery
* There is no clinical or radiological evidence of distant metastasis
* Expander removal combined with prosthesis implantation is planned
* Able and willing to sign an informed consent

Exclusion Criteria

* The first SSM/NSM combined expander implantation was performed via axillary approach
* Patients participate in other clinical trial, which could potentially affect their participation in this trial
* Adjuvant radiotherapy was planned post-operation
* Patient who is pregnant and lactating
* The expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hangzhou First People's Hospital, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Chao NI

Role: CONTACT

Phone: +8613989463951

Email: [email protected]

Other Identifiers

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IRB-2022- 1451

Identifier Type: -

Identifier Source: org_study_id