Cosmetic results for patients with breast cancer operated with bilateral reduction mammoplasty
| ISRCTN | ISRCTN82786416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82786416 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Region Skåne |
| Funders | Lunds Universitet, Region Skåne |
- Submission date
- 10/10/2019
- Registration date
- 08/11/2019
- Last edited
- 05/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Breast cancer affects thousands of women in Sweden every year and is the most common type of cancer in women. In the year 2016 as many as 7500 women in Sweden were diagnosed with breast cancer. Using oncoplastic techniques in breast cancer surgery allows for a generous resection of breast tissue and therefore a reduction in non-radical surgery and studies has also shown that patients are more satisfied with the cosmetic outcome. The use of breast-reduction techniques is one of the most commonly used in oncoplastic breast surgery. Bilateral breast reduction in combination with breast-cancer surgery (therapeutic mammoplasty) has the benefit of reducing the volume of the breasts as well as assuring good symmetry after surgery. In patients with breast cancer combined with mammary hyperplasia and a good health status it is a valuable option to consider, even with smaller tumours. The INESC porto research group has created software called Breast Cancer Conservative Treatment cosmetic results (BCCT.core) which assesses photographs and produces a rated result: poor, fair, good or excellent aesthetic outcome. The evaluation is based on symmetry, skin colour and scar appearance. The main study aim is to assess the cosmetic outcome, evaluated by BCCT.core, at the time of breast cancer diagnosis, after bilateral therapeutic mammoplasty and at 1-year follow-up.
Who can participate?
Patients who underwent bilateral therapeutic mammoplasty between 2011 and August 2018 (data collected from digital patient records)
What does the study involve?
For the postoperative photos information is extracted from BCCT.core including the 4-grade cosmetic outcome and a value for symmetry between the breasts. For the preoperative photos BCCT.core is used only to extract the symmetry score, since BCCT.core is designed for evaluating the cosmetic outcome for postoperative photos. Values on a 10-grade scale for cosmetic outcomes are recorded for both patient and surgeon on 1-year follow-up. The surgeon’s and patient’s grading of cosmetic outcome is made primarily on the 1-year follow-up, with a few exceptions where it is done in retrospect by the surgeon based on the postoperative photos.
What are the possible benefits and risks of participating?
The possible benefits are that it can lead to a better understanding of the cosmetic outcomes for patient undergoing this type of surgery, so surgeons in the future can make the best possible choices regarding surgery for breast cancer patients. There are no potential risks for the patients involved since this is a register study only, also all the patients have been de-identified in the dataset. There was also an opt-out option available for the potential patients in the study, in form of an article in the local newspaper calling on patients who fulfilled the inclusion criteria to contact the responsible party if they did not wish to participate.
Where is the study run from?
Kirurgen, Centralsjukhuset Kristianstad (Sweden)
When is the study starting and how long is it expected to run for?
October 2018 to October 2019
Who is funding the study?
1. Lunds Universitet (Sweden)
2. Region Skåne (Sweden)
Who is the main contact?
Dr Kim Gulis
Kim.Gulis@skane.se
Contact information
Scientific
J A Hedlundsv 5
Kristianstad
29133
Sweden
 ORCID ID |
0000-0002-4089-0760 |
|---|---|
| Phone | +46 (0)44-3092286 |
| kim.gulis@skane.se |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational cohort study |
| Secondary study design | Cohort study |
| Scientific title | Cosmetic outcome and symmetry for patients who have undergone bilateral therapeutic mammoplasty for breast cancer |
| Study objectives | To evaluate the cosmetic outcome after bilateral therapeutic mammoplasty. |
| Ethics approval(s) | Approved 04/12/2018, Etikprövningsnämnden i Lund (Box 133, 22100, Lund, Sweden; Tel: +46 (0)104750800; Email: registrator@etikprovning.se), Dnr 2018/827 |
| Health condition(s) or problem(s) studied | Cosmetic outcome after breast cancer surgery |
| Intervention | The patients eligible for inclusion is all patients operated with bilateral therapeutic mammoplasty between 2011 and until August 2018, the patients were identified and the data was retrospectively collected from digital patient records. Regarding the aesthetic outcome from a more impartial view, INESC porto research group has created an objective software called the Breast Cancer Conservative Treatment cosmetic results (BCCT.core). This software assesses photographs and produces a rated result: poor, fair, good or excellent aesthetic outcome. The evaluation is based on symmetry, skin colour and scar appearance. For the postoperative photos, information is extracted from BCCT.core including the 4-grade cosmetic outcome and a value for symmetry between the breasts. For the preoperative photos, BCCT.core is used only to extract the symmetry score, since BCCT.core is designed for evaluating the cosmetic outcome for postoperative photos. Values on a 10-grade scale for cosmetic outcomes have been registered for both patient and surgeon on 1-year follow-up. The surgeons and patients grading of cosmetic outcome was made primarily on the 1-year follow-up, with few exceptions where it was done in retrospect by the surgeon based on the postoperative photos. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Cosmetic outcome measured using BCCT.core score on a 4-grade scale 1-year postoperatively |
| Key secondary outcome measure(s) |
1. Complications documented for each breast separately according to Clavien-Dindo classification 2 weeks postoperatively and 1 year postoperatively |
| Completion date | 01/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 150 |
| Total final enrolment | 146 |
| Key inclusion criteria | All patients operated with bilateral therapeutic mammoplasty between 2011 and August 2018 in Centralsjukhuset Kristianstad |
| Key exclusion criteria | 1. Patients who had a mastectomy before the 1-year postoperative follow-up 2. Patients who had a nipple removed during the surgery due to tumor location 3. Patients where the postoperative 1-year photos were missing 4. Patients who died before the 1-year follow-up |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Kristianstad
29133
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2021 | 05/02/2021 | Yes | No |
Editorial Notes
05/02/2021: Publication reference added.
10/10/2019: Trial's existence confirmed by ethics committee.
