Clinical trial NCT03535012: Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options
Official title: Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted by dividing the subjects into two groups(25 per each arm) according to the method of reconstruction: implant vs. abdominal tissue. It is difficult to determine a sample size that can establish statistical significance based on previous studies. Therefore, the number of targeted subjects was estimated based on the number of patients that can generally be recruited during the study period.

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.


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

Primary outcomes:
measure: Sensory recovery in the reconstructed breast according to reconstructive options
timeFrame: 3 months (±1 month) after immediate breast reconstruction surgery
measure: Sensory recovery in the reconstructed breast according to reconstructive options
timeFrame: 6 months (±1 month) after immediate breast reconstruction surgery
measure: Sensory recovery in the reconstructed breast according to reconstructive options
timeFrame: 12 months (±2 months) after immediate breast reconstruction surgery
measure: Sensory recovery in the reconstructed breast according to reconstructive options
timeFrame: 18 months (±2 months) after immediate breast reconstruction surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
Study officials:
References: