Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options

NCT ID: NCT03535012

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2020-02-28

Brief Summary

Over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. Advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed.

With such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. Due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. There has been little research on the mechanism of sensory recovery despite its clinical importance. This study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Reconstruction using an implant

Immediate 2 stage implant based breast reconstruction after mastectomy. All expanders are placed in the subpectoralis muscle using ADM as a sling. After expansion of the tissue expander change to the permanent implant is performed.

No interventions assigned to this group

Reconstruction using abdominal tissue

immediate free DIEP flap breast reconstruction after mastectomy. DIEP(deep inferior epigastric perforator) free flap was prepared and transferred to the breast pocket. Microanastomosis was done under the microscopic magnification. On sitting position, free flap was inset into breast pocket with confirming of satisfactory inflammatory fold.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female adults over 20 years of age
• Patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ)
• written consent to study participation

Exclusion Criteria

• presence of neuropathy that may hinder accurate assessment of sensation
• presence of dermatological condition that may hinder accurate assessment of sensation
• inability to provide written consent
• decided by the research team to be unsuitable for this study

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Dongwon Lee, MD, Ph.D

Role: primary

XYPHOSS@yuhs.ac

82-2-2228-2215

Other Identifiers

4-2015-1019

Identifier Type: -

Identifier Source: org_study_id