Breast CancerNCT03535012
Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options
An observational study of Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2016to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
Seoul, 03722
Dongwon Lee, MD, Ph.D, 82-2-2228-2215, XYPHOSS@yuhs.ac
About this study
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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory recovery in the reconstructed breast according to reconstructive options
Subjects will be followed up with quantitative sensory testing at 3 months (±1 month) after immediate breast reconstruction surgery.
Measured: 3 months (±1 month) after immediate breast reconstruction surgery
Sensory recovery in the reconstructed breast according to reconstructive options
Subjects will be followed up with quantitative sensory testing at 6 months (±1 month) after immediate breast reconstruction surgery.
Measured: 6 months (±1 month) after immediate breast reconstruction surgery
Sensory recovery in the reconstructed breast according to reconstructive options
Subjects will be followed up with quantitative sensory testing at 12 months (±2 months) after immediate breast reconstruction surgery.
Measured: 12 months (±2 months) after immediate breast reconstruction surgery
Sensory recovery in the reconstructed breast according to reconstructive options
Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery.
Measured: 18 months (±2 months) after immediate breast reconstruction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Sep 2016
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535012
- Sponsor's protocol ID
- 4-2015-1019
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options
- ClinicalTrials.gov ID
- NCT03535012
- Acronym / sponsor ID
- 4-2015-1019
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory recovery in the reconstructed breast according to reconstructive options
Time frame: 3 months (±1 month) after immediate breast reconstruction surgery
Subjects will be followed up with quantitative sensory testing at 3 months (±1 month) after immediate breast reconstruction surgery.
Sensory recovery in the reconstructed breast according to reconstructive options
Time frame: 6 months (±1 month) after immediate breast reconstruction surgery
Subjects will be followed up with quantitative sensory testing at 6 months (±1 month) after immediate breast reconstruction surgery.
Sensory recovery in the reconstructed breast according to reconstructive options
Time frame: 12 months (±2 months) after immediate breast reconstruction surgery
Subjects will be followed up with quantitative sensory testing at 12 months (±2 months) after immediate breast reconstruction surgery.
Sensory recovery in the reconstructed breast according to reconstructive options
Time frame: 18 months (±2 months) after immediate breast reconstruction surgery
Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory recovery in the reconstructed breast according to reconstructive options (time frame: 3 months (±1 month) after immediate breast reconstruction surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.